MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01 report with the FDA on 2013-07-02 for IDRT SINGLE LAYER (INTL) 2X2 5 PACK 62025 manufactured by Integra Lifesciences Corporation.
[3579686]
It was reported that the product was implanted in a 1 step surgery with skingraft on (b)(6) 2013. But at the 30 day visit on (b)(6) 2013, the surgeon mentioned a graft loss of about 80% with bone exposure. A flap surgery was done to solve the problem. The wound was a reconstruction after excision of a basal cell carcinoma.
Patient Sequence No: 1, Text Type: D, B5
[11075551]
Please note: this idrt (integra dermal regeneration template) single layer product is not sold in the united states. The device involved in the reported incident is not expected to be received for evaluation. An investigation has been initiated based upon the reported information.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1121308-2013-00037 |
| MDR Report Key | 3208916 |
| Report Source | 01 |
| Date Received | 2013-07-02 |
| Date of Report | 2013-07-02 |
| Date Mfgr Received | 2013-06-12 |
| Date Added to Maude | 2013-07-09 |
| 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 | ROWENA SALVADOR |
| Manufacturer Street | 315 ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099362393 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IDRT SINGLE LAYER (INTL) 2X2 5 PACK |
| Generic Name | IDRT |
| Product Code | MGR |
| Date Received | 2013-07-02 |
| Catalog Number | 62025 |
| Lot Number | 105B00258246 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA LIFESCIENCES CORPORATION |
| Manufacturer Address | PLAINSBORO NJ 08536 US 08536 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2013-07-02 |