MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,02,05,07 report with the FDA on 2014-10-21 for IDRT SINGLE LAYER (INTL) 2X2 SINGLE 62021 manufactured by Integra Lifesciences Corp..
[5148858]
This event is being reported as part of a study in greece titled "clinical outcome of defect reconstruction using idrt single layer: results from a prospective multicentric trial". It was reported the pt 'was operated on (b)(6) 2013 with idrt sl 1 stage. But on (b)(6) 2013, 15% graft less with tendon exposure. No treatment. Follow-up. On (b)(6) 2014, the wound completely healed'.
Patient Sequence No: 1, Text Type: D, B5
[12212616]
The device involved in the reported incident is not available for eval. An investigation has been initiated based on the reported info.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1121308-2014-00067 |
| MDR Report Key | 4195829 |
| Report Source | 01,02,05,07 |
| Date Received | 2014-10-21 |
| Date of Report | 2014-09-29 |
| Date of Event | 2013-06-10 |
| Date Mfgr Received | 2014-09-29 |
| Date Added to Maude | 2014-10-24 |
| 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 FINKELSTEIN |
| Manufacturer Street | 315 ENTERPRISE DR. |
| 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 | IDRT SINGLE LAYER (INTL) 2X2 SINGLE |
| Generic Name | IDRT |
| Product Code | MGR |
| Date Received | 2014-10-21 |
| Catalog Number | 62021 |
| Lot Number | 105A00254166 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA LIFESCIENCES CORP. |
| Manufacturer Address | PLAINSBORO NJ 08536 US 08536 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-10-21 |