MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2016-11-03 for IDRT, UNKNOWN XXX-IDRT manufactured by Integra Lifesciences Corporation.
[59040830]
It was reported the dermal graft failed/did not work. The surgeon reported a clinical case of a trauma on the dorsum of a foot of a (b)(6) child. Surgical debridement was performed in the or followed by the application of idrt and negative pressure wound therapy (npwt). After 6 weeks from surgery the dermal substitute looked fully integrated at 100% with the typical peach/vanilla color. Silicon layer was removed and after gentle brushing on the neo-dermis surface a thin stsg was harvested from the gluteal region of the child. After 5 days from the application and compressive dressing the non-take of the graft on the wound bed was assessed. In sequence: debridement, idrt fixation, idrt taking successfully, application of epidermal auto graft, non-take of the auto graft and healing by secondary intention. It was reported no patient injury is alleged.
Patient Sequence No: 1, Text Type: D, B5
[61515108]
Integra completed its internal investigation 23nov2016. The investigation included: method: review of complaint management database for similar complaints. Results: no product lot number was provided for the product involved with this complaint; therefore, dhr review cannot be performed. A query of the complaint database was performed for all wound dressing management products. There was one additional complaint found. A lot query could not be performed as there was no product lot number reported with this complaint. Conclusion: the root cause is undetermined. The device is still in contact with the patient.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1121308-2016-00020 |
| MDR Report Key | 6075454 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2016-11-03 |
| Date of Report | 2016-10-12 |
| Date Mfgr Received | 2016-11-23 |
| Date Added to Maude | 2016-11-03 |
| 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 |
| Reporter Occupation | DENTAL HYGIENIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | USER MARIA LEONARD |
| 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 | IDRT, UNKNOWN |
| Generic Name | INTEGRA |
| Product Code | MDD |
| Date Received | 2016-11-03 |
| Catalog Number | XXX-IDRT |
| 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 CORPORATION |
| Manufacturer Address | 105 MORGAN LANE 105 MORGAN LANE PLAINSBORO NJ 08536 US 08536 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-11-03 |