MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07,08 report with the FDA on 2014-09-26 for IDR-TS 8X10 5 PACK DOMESTIC 38105 manufactured by Integra Lifesciences Corp..
[4926869]
It was reported expired product was implanted in pt surgery. Pt has had an excellent result with the skin. There was no reported injury or adverse consequence to the pt.
Patient Sequence No: 1, Text Type: D, B5
[12422952]
The device involved in the reported incident is not available for evaluation. An investigation has been initiated based on the reported info.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1121308-2014-00061 |
| MDR Report Key | 4137460 |
| Report Source | 07,08 |
| Date Received | 2014-09-26 |
| Date of Report | 2014-09-02 |
| Date of Event | 2014-08-02 |
| Date Mfgr Received | 2014-09-02 |
| Date Added to Maude | 2014-10-08 |
| 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 | IDR-TS 8X10 5 PACK DOMESTIC |
| Generic Name | IDRT-TS |
| Product Code | MGR |
| Date Received | 2014-09-26 |
| Catalog Number | 38105 |
| Lot Number | 105C00250730 |
| Device Expiration Date | 2014-05-31 |
| 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 | 2014-09-26 |