MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06,08 report with the FDA on 2014-07-15 for INTEGRA MESHED BILAYER WOUND MATRIX SIZE 4 X 10 MWM4101 manufactured by Integra Lifesciences Corp..
[19394002]
The device involved in the reported incident is not available for evaluation. An investigation has been initiated based upon the reported info.
Patient Sequence No: 1, Text Type: N, H10
[19482933]
It was reported that "outcome of defected reconstruction using idrt was a formation of a white lump. The phenomenon gives a good reason for the surgeon to attribute this formation of lump to the use of idrt. " on (b)(6) 2014 after debridement (of a crushed wound) idrt was applied to skin defect on the pt's right calf, toward the achilles tendon. A vacuum assisted closure (vac) dressing was also applied to the wound. On (b)(6) 2014 pus was admitted. The silicone layer was once removed for debridement. A culture was obtained from the wound site cns (coagulase-negative staphylococci) was confirmed by culture. The wound was "cleared" and metronidazole ointment (original made within the hosp) was applied. On (b)(6) 2014 neodermis formation (good vanilla in color) was admitted. Autograft was taken from pt's hip and applied. "the autograft taken was good and the pt was discharged from hosp. " "after discharge from the hosp (approximately a week after auto-grafting, the reconstructed defect was reported to be uneven and somewhat stiff. The surgeon dissected a part and dry powder (something similar to white chalk) came out from the wound. " "smooth/good reconstruction was observed only on part poor take of idrt observed and infection was suspected. " on (b)(6) 2014 "the pt visited the hosp for wound getting uneven. " on (b)(6) 2014 "the dry defect was dissected. " add'l info was received on (b)(6) 2014. "it was not "powderly," but more "paste-like. " since this hosp is not conducting further investigation on the "substance" the samples of "white paste-like substance" were sent to (b)(4) for investigation and they sent a prompt reports as follows "specimen: white substance; results: the above substance is largely composed of squamous cells. " the pt is currently "under a f/u once a week. Metronidazole ointment is applied to dry dissect every time. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1121308-2014-00023 |
| MDR Report Key | 3960526 |
| Report Source | 01,06,08 |
| Date Received | 2014-07-15 |
| Date of Report | 2014-06-24 |
| Date of Event | 2014-04-30 |
| Date Mfgr Received | 2014-06-24 |
| Date Added to Maude | 2014-08-04 |
| 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 | INTEGRA MESHED BILAYER WOUND MATRIX SIZE 4 X 10 |
| Generic Name | NA |
| Product Code | MGR |
| Date Received | 2014-07-15 |
| Catalog Number | MWM4101 |
| Lot Number | 105NA0259476 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| 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 | 1. Required No Informationntervention | 2014-07-15 |