MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-01-10 for CROW DRES COAG FCP TC 9IN PM-9043 manufactured by Integra York, Pa Inc..
[17559342]
During a breast augmentation the pt was burned on the areola of the left breast along the incision line. Steri-strips were applied as is the physician's standard for breast augmentation, no additional treatment was provided. The surgical assistant reported the pt was seen twice since the surgery and the burn was healing without scar.
Patient Sequence No: 1, Text Type: D, B5
[17706989]
To date the device involved in the reported incident has not been received for evaluation. An investigation has been initiated based on the reported information.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2523190-2011-00093 |
| MDR Report Key | 2413167 |
| Report Source | 05,06 |
| Date Received | 2012-01-10 |
| Date of Report | 2012-01-10 |
| Date of Event | 2011-12-28 |
| Date Mfgr Received | 2011-12-29 |
| Date Added to Maude | 2012-01-13 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | CAREN FERNANDEZ |
| Manufacturer Street | 315 ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099362341 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CROW DRES COAG FCP TC 9IN |
| Generic Name | M12 - PLASTIC SURGERY |
| Product Code | FTN |
| Date Received | 2012-01-10 |
| Catalog Number | PM-9043 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA YORK, PA INC. |
| Manufacturer Address | YORK PA 17402 US 17402 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-01-10 |