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The Department of Health (DH) today (November 25) instructed a local medical device distributor, DKSH Hong Kong Limited, to recall from users and consumers all affected batches of 1.5cc Radiesse Dermal Filler syringes manufactured by Merz Aesthetics (MA) in the US because of a quality defect with a possible threat to safety.
The DH first came to learn of the incident through its surveillance scheme for medical devices. It was noted yesterday (Hong Kong time) that the US Food and Drug Administration (FDA) has issued an enforcement report about a trade-initiated global recall of the above product, ongoing since this August.
"MA is recalling the product because it has identified a defect in certain lots such that the dermal filler may leak past the plunger at the proximal end of the syringe when in use," a DH spokesman explained.
"Messiness aside, microbial contamination and hence resulting hygienic deficiency and even infection can become very real concerns. Regarding the latter, it is a little reassuring to find that thus far, there has been no report of a related adverse event anywhere," the spokesman said.
In response to the gap between the recall commencement and reporting, the spokesman said that the DH noted that this has been an ongoing US practice.
"Regardless, our officers began investigation immediately. Enquiry to MA's regional representation in Singapore revealed that there was a history of Hong Kong having imported the affected batches, with DKSH as our local distributor," the spokesman continued.
The spokesman said that DKSH told DH staff that it is only responsible for delivery. Clients actually placed orders with MA's regional representation in Singapore directly.
"Further investigation into DKSH's trade records showed that it has distributed two of the affected batches (numbers: 1023912 and 1023913), comprising about 1,000 pieces, to Prince of Wales Hospital and another business, Micromed Limited (Micromed), between March and May this year," the spokesman said.
"In view of the quality defect identified, in particular because consequential safety threats cannot be ruled out, we urge that use of the batches concerned be ceased with immediate effect. To curb further use, we have also directed DKSH to collect the remaining stocks from PWH and Micromed. In addition, we will also advise the latter to contact their clients for possible checks on ill effects besides putting them under medical surveillance," the spokesman remarked.
"In case members of the public still have the products in their possession, they can either return them to DKSH or to the DH's Medical Device Control Office at Room 3101, 31/F, Hopewell Centre, 183 Queen's Road East, Wan Chai. DKSH has already set up a hotline at phone number 2895 9302 to handle public enquiries," the spokesman said.
The spokesman also reminded the public that anyone who is not clear or feeling unwell after having used the product should consult health-care professionals.
Meanwhile, the investigation continues.
Ends/Friday, November 25, 2011
Issued at HKT 21:15
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