MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2014-05-15 for OTOFORM K NC12006 manufactured by North Coast Medical, Inc..
[4609453]
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.
Patient Sequence No: 1, Text Type: D, B5
[12052100]
Additional lot #: 204050, additional expiration date: 04/2015.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2939821-2014-00018 |
| MDR Report Key | 3958648 |
| Report Source | 08 |
| Date Received | 2014-05-15 |
| Date of Report | 2014-04-15 |
| Date of Event | 2014-04-08 |
| Date Mfgr Received | 2014-04-15 |
| Date Added to Maude | 2014-08-04 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | 8100 CAMINO ARROYO |
| Manufacturer City | MORGAN HILL CA 95020 |
| Manufacturer Country | US |
| Manufacturer Postal | 95020 |
| Manufacturer Phone | 8008219319 |
| Manufacturer G1 | DREVE AMERICA |
| Manufacturer Street | 5421 FELTI ROAD STE 160 |
| Manufacturer City | MINNETONKA MN 55343 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55343 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OTOFORM K |
| Generic Name | PUTTY |
| Product Code | MDA |
| Date Received | 2014-05-15 |
| Model Number | NC12006 |
| Catalog Number | NC12006 |
| Lot Number | 204173 |
| Device Expiration Date | 2014-05-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NORTH COAST MEDICAL, INC. |
| Manufacturer Address | GILROY CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-05-15 |