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 |