FDA Adverse Event
Malfunction
Summary report: N
OTOFORM K
MDR report key: 3958648
·
Received May 15, 2014
Report
- Report Number
- 2939821-2014-00018
- Event Type
- Malfunction
- Date Received
- May 15, 2014
- Date of Event
- April 8, 2014
- Report Date
- April 15, 2014
- Manufacturer
- NORTH COAST MEDICAL, INC.
- Product Code
- MDA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL LOT #: 204050, ADDITIONAL EXPIRATION DATE: 04/2015.
Description of Event or Problem · 1
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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 290899 | OTOFORM K | PUTTY | MDA | NORTH COAST MEDICAL, INC. | NC12006 | 204173 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | PATIENT USED PRODUCT WITH BLUE PERFORATED| POLYFORM THERMOPLASTIC SPLINT |