MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,08 report with the FDA on 2014-02-27 for IDRT-TS (INTL) SINGLE 2X2 82021 manufactured by Integra Lifesciences Corp.
[15205992]
This is the second report of two concerning the same product with the same reported issue. (see mfg report number 1121308-2014-00007). This report concerns the second idrt. It was reported "during a surgery when the first idrt was opened, polyethylene sheets were found to have been shifted slightly and formed wrinkles on idrt. The product was not used for the surgery. A second idrt was opened with the same issue. A third idrt was opened and applied to a pt to finish the surgery.
Patient Sequence No: 1, Text Type: D, B5
[15788445]
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 | 1121308-2014-00008 |
| MDR Report Key | 3727545 |
| Report Source | 01,08 |
| Date Received | 2014-02-27 |
| Date of Report | 2014-02-12 |
| Date Mfgr Received | 2014-02-12 |
| Date Added to Maude | 2014-05-12 |
| 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 DRIVE |
| Manufacturer City | PLAINSBORO NJ 8536 |
| Manufacturer Country | US |
| Manufacturer Postal | 8536 |
| Manufacturer Phone | 6099362341 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IDRT-TS (INTL) SINGLE 2X2 |
| Generic Name | IDRT-TS |
| Product Code | MGR |
| Date Received | 2014-02-27 |
| Catalog Number | 82021 |
| Lot Number | 105NA0277860 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2014-02-27 |