MalfunctionMDA
OTOFORM K
Received May 15, 2014 · Event occurred Apr 8, 2014
Report 2939821-2014-00018 · MDR key 3958648
Device
Generic name
Putty
Manufacturer
North Coast Medical, Inc.Model number
NC12006Catalog number
NC12006
Lot number
204173
Product problems
- Device Operates Differently Than Expected
Patient
65 YR
- Itching Sensation
- Reaction
Narrative
Description of Event or Problem
THE PRODUCT IS A PUTTY-LIKE SILICONE USED TO HELP SOFTEN AND FLATTEN HYPERTROPHIC SCARRING. THE HARDENER PASTE OF THE PRODUCT IS TO BE MIXED WITH THE PUTTY BEFORE USE. THE PATIENT REPORTED SIGNIFICANT ITCHING AND ALLEGED ALLERGIC REACTION WITH THE PRODUCT. THE OT INSTRUCTED THE PATIENT TO DISCONTINUE USE OF THE PRODUCT. THE PATIENT REPORTED AFFECTED AREA IS SIGNIFICANTLY BETTER SINCE DISCONTINUING USE OF THE PRODUCT.
Additional Manufacturer Narrative
ADDITIONAL LOT #: 204050, ADDITIONAL EXPIRATION DATE: 04/2015.