MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a literature report with the FDA on 2018-01-31 for IDRT, UNKNOWN XXX-IDRT manufactured by Integra Lifesciences Corporation.
[98701375]
Two (2) of 2 reports - other mfg report number: 1121308-2018-00004. The device involved in the reported incident is not available for evaluation. The plant investigation is in progress and a supplemental medwatch report will be submitted upon completion of the investigation.
Patient Sequence No: 1, Text Type: N, H10
[98701376]
Two (2) of 2 reports: the plastic and reconstructive surgery journal (2017) published:? A retrospective look at integrating a novel regenerative medicine approach in plastic limb reconstruction?. The purpose of this retrospective study was to evaluate the effectiveness of an innovative approach whereby several therapies were combined to avoid amputation. Seventeen (17) patients with full-thickness wounds who were previously recommended for amputation and were treated with the combinatorial approach of muscle flap reconstruction and concentrated bone marrow aspirate, platelet-rich plasma, integra wound matrix, vacuum-assisted closure, and split-thickness skin grafts were assessed retrospectively. There were hematomas present at the harvest site in 2 of the 17 patients: 1 hematoma required evacuation. This was considered a postoperative complication.
Patient Sequence No: 1, Text Type: D, B5
[114572515]
Investigation completed on (b)(6) 2018. No product lot number is provided so a dhr review could not be conducted. All product is released based on passing of all in process and finished goods criteria. This includes ensuring that sterile product gets to the customer. The hematomas and above-the-knee amputation (aka) reported are likely related to the procedure and not idrt. The hematomas were at the donor sites and not at the idrt application sites.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1121308-2018-00003 |
| MDR Report Key | 7231872 |
| Report Source | LITERATURE |
| Date Received | 2018-01-31 |
| Date of Report | 2018-01-08 |
| Date Mfgr Received | 2018-02-16 |
| Date Added to Maude | 2018-01-31 |
| 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 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 | KGN |
| Date Received | 2018-01-31 |
| 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 | 2018-01-31 |