MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2013-04-16 for BILAYER MATRIX WOUND DRESSING 4X5 5 PACK BMW405 manufactured by Integra Lifesciences Corp..
[16751583]
The reporter noted: "there was a hole in the integra bilayer matrix wound dressing's foil packaging. Fluid was noted between the foil package and plastic package. The fluid was not leaking out of the plastic package. There was no pt contact and a 5 minute delay in surgery due to this. Additional info has been requested regarding lot # and product return status.
Patient Sequence No: 1, Text Type: D, B5
[17001506]
To date, the device involved in the reported incident has not been received for eval. An investigation has been initiated based upon the reported info.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1121308-2013-00003 |
| MDR Report Key | 3066361 |
| Report Source | 05,06,07 |
| Date Received | 2013-04-16 |
| Date of Report | 2013-04-16 |
| Date Mfgr Received | 2013-03-27 |
| Date Added to Maude | 2013-06-20 |
| 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 | CAREN FINKELSTEIN |
| Manufacturer Street | 315 ENTERPRISE DR |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099362341 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BILAYER MATRIX WOUND DRESSING 4X5 5 PACK |
| Generic Name | BMWD |
| Product Code | MGR |
| Date Received | 2013-04-16 |
| Catalog Number | BMW405 |
| Operator | HEALTH PROFESSIONAL |
| Device Eval'ed by Mfgr | R |
| 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 | 2013-04-16 |