MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-03 for OMNIGRAFT AND DISPOSABLE STAPLER KIT 7CM X 7CM DFU7071S manufactured by Integra Lifesciences Corp.
[140883504]
The device is not expected to be returned to the manufacturer for analysis. The plant investigation is in progress and a supplemental medwatch report will be submitted upon completion of the investigation (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[140883505]
The customer reported that within 24 hours of omigraft (id (b)(4)) application, a (b)(6) y/o male patient experienced extreme burning pain, redness, and swelling and was diagnosed with cellulitis. This resulted in hospitalization for sepsis from the wound, and further skin deterioration of foot and toes. The standard protocol was performed for application. The patient is doing well; however, the wound has worsened. Wound therapy will be continued.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9680091-2019-00004 |
| MDR Report Key | 8480640 |
| Date Received | 2019-04-03 |
| Date of Report | 2019-03-08 |
| Date of Event | 2019-02-21 |
| Date Mfgr Received | 2019-04-09 |
| Date Added to Maude | 2019-04-03 |
| 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 CORP |
| Manufacturer Street | 311 ENTERPRISE DRIVE |
| 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 | 0 |
| Brand Name | OMNIGRAFT AND DISPOSABLE STAPLER KIT 7CM X 7CM |
| Generic Name | INTEGRA OMNIGRAFT DERMAL REGENERATION MATRIX |
| Product Code | MDD |
| Date Received | 2019-04-03 |
| Catalog Number | DFU7071S |
| Lot Number | 2499427 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA LIFESCIENCES CORP |
| Manufacturer Address | 311 ENTERPRISE DRIVE 311 ENTERPRISE DRIVE PLAINSBORO NJ 08536 US 08536 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-04-03 |