MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2018-03-15 for INTEGRA? WOUND MATRIX (THIN) 4 X 5 1 PACK DOMESTIC 54051T manufactured by Integra Lifesciences Corporation.
[102497017]
Investigation completed on (b)(6) 2018. The complaint device was not returned for evaluation. All applicable manufacturing equipment underwent sterilization at the required temperature and time conditions. All appropriate work orders were generated and completed per the requirements. Based on the dhr review conducted, there is no indication that the production process may have contributed to this complaint. All test results passed the procedural specifications, and there were no defects observed related to error in expiry or releasing/distributing expired material. The device was not returned to the manufacturer failure analysis. The failure is unconfirmed. The expiration date for integra wound matrix thin (b)(4) product is calculated as 24 months from the start of manufacturing. The lot number and expiration date of each (b)(4) product are labeled on the outer box as well as on a patient sticker label, which is placed on the inner tyvek pouch. The expiration date of the piece of product used was (b)(6) 2017. The most probable cause of this complaint is the customer? S inventory management system. The expiration date of the (b)(4) product used in surgery was likely not checked prior to surgery and use.
Patient Sequence No: 1, Text Type: N, H10
[102497018]
It was reported that on (b)(6) 2018, a 54051t integra wound matrix (thin) was implanted. However, the product was expired with an expiry date of (b)(6) 2018. The following day, the patient was taken back to the operating room (or) to have the expired product removed from the patient's body and replaced with a new piece. No patient injury were reported. Additional information has been requested.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1121308-2018-00019 |
| MDR Report Key | 7341657 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-03-15 |
| Date of Report | 2018-02-23 |
| Date of Event | 2018-02-23 |
| Date Mfgr Received | 2018-02-23 |
| Date Added to Maude | 2018-03-15 |
| 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) 4 X 5 1 PACK DOMESTIC |
| Generic Name | DERMAL REPAIR (SKIN) |
| Product Code | KGN |
| Date Received | 2018-03-15 |
| Catalog Number | 54051T |
| Lot Number | 105A00328588 |
| Device Expiration Date | 2017-05-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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. Required No Informationntervention | 2018-03-15 |