MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign report with the FDA on 2018-03-05 for IDRT TS INTL 1PK 4X10 84101 manufactured by Integra Lifesciences Corporation.
[101525703]
The device involved in the reported incident is not available for evaluation. An investigation has been initiated based on the reported information.
Patient Sequence No: 1, Text Type: N, H10
[101525704]
It was reported that the plaster was placed on idrt and part of matrix was infected. According to sales manager no product non-conformance was reported. She thought it could be "misuse" as plaster is usually recommended for tendons. Implantation location - forearm.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1121308-2018-00018 |
| MDR Report Key | 7314042 |
| Report Source | FOREIGN |
| Date Received | 2018-03-05 |
| Date of Report | 2018-02-14 |
| Date Mfgr Received | 2018-03-13 |
| Date Added to Maude | 2018-03-05 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | USER SONIA IRIZARRY |
| Manufacturer Street | 311 ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099362393 |
| Manufacturer G1 | INTEGRA LIFESCIENCES CORPORATION |
| Manufacturer Street | 105 MORGAN LANE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 08536 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IDRT TS INTL 1PK 4X10 |
| Generic Name | INTEGRA |
| Product Code | MDD |
| Date Received | 2018-03-05 |
| Catalog Number | 84101 |
| Lot Number | 1/353529 |
| 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 | 105 MORGAN LANE 105 MORGAN LANE PLAINSBORO NJ 08536 US 08536 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-03-05 |