MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2014-11-04 for INTEGRA MATRIX WOUND DRESSING 8X10 SINGLE DOMESTIC 58101 manufactured by Integra Lifesciences Corp..
[5006284]
It was reported "when customer opened first layer there was fluid in the protective layer meaning fluid was leaking from sterile pouch compromising sterility and integrity. " the product was not in contact with a patient or used for a patient surgery.
Patient Sequence No: 1, Text Type: D, B5
[12565303]
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
| Report Number | 1121308-2014-00069 |
| MDR Report Key | 4262034 |
| Report Source | 08 |
| Date Received | 2014-11-04 |
| Date of Report | 2014-10-10 |
| Date of Event | 2014-09-01 |
| Date Mfgr Received | 2014-10-10 |
| Date Added to Maude | 2014-11-20 |
| 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 | ROWENA BUNUAN |
| Manufacturer Street | 315 ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099362393 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INTEGRA MATRIX WOUND DRESSING 8X10 SINGLE DOMESTIC |
| Generic Name | NA |
| Product Code | MGR |
| Date Received | 2014-11-04 |
| Catalog Number | 58101 |
| Lot Number | 105NB02286521 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| 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 | 2014-11-04 |