MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,health professional report with the FDA on 2018-08-14 for INTEGRA? WOUND MATRIX (THIN) 2 X 2 1 PACK DOMESTIC 52021T manufactured by Integra Lifesciences Corporation.
[117299145]
The product was not returned to the manufacturer for physical evaluation. The failure is unconfirmed. The most probable cause of this complaint is the customer? S inventory management system. The expiration date of the iwm-t product used in surgery was likely not checked prior to surgery and use.
Patient Sequence No: 1, Text Type: N, H10
[117299146]
A distributor reported on behalf of the customer that on (b)(6) 2018, an expired integra wound matrix was implanted. The patient was prepped for surgery and the product was taken by a nurse out of the implant coordinators empty office and was implanted without an integra representative aware. The hospital has taken responsibility for the incident. There was no delay in procedure and no patient injury were reported. Additional information has been requested.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1121308-2018-00028 |
| MDR Report Key | 7781129 |
| Report Source | CONSUMER,HEALTH PROFESSIONAL |
| Date Received | 2018-08-14 |
| Date of Report | 2018-07-18 |
| Date of Event | 2018-07-08 |
| Date Mfgr Received | 2018-07-18 |
| Device Manufacturer Date | 2016-08-11 |
| Date Added to Maude | 2018-08-14 |
| 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 VIVIAN NELSON |
| 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 | INTEGRA? WOUND MATRIX (THIN) 2 X 2 1 PACK DOMESTIC |
| Generic Name | DERMAL REPAIR (SKIN) |
| Product Code | KGN |
| Date Received | 2018-08-14 |
| Catalog Number | 52021T |
| Lot Number | 105A00352117 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| 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 | 2018-08-14 |