MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-11-20 for FLOWABLE WOUND MATRIX - UNSPECIFIED XXX-FLOWABLE manufactured by Integra Lifesciences Corp.
[31796251]
Reportedly the patient was treated with an integra product (flowable wound matrix) by the podiatrist named as the defendant. The provided documents indicate the patient suffered serious and permanent injury to her right foot, causing severe pain with ambulation and the need for future surgery, physical therapy, and other treatment. It is alleged the care of this patient involved negligent acts and/or omissions that did not comply with the "standard of care. " additional information has been requested.
Patient Sequence No: 1, Text Type: D, B5
[36607522]
Integra has completed their internal investigation on 12/21/2015. The investigation included: methods: review of complaints history. Results: no product lot number was provided with this complaint; therefore, dhr review cannot be performed. If the product lot number is provided at a later date, dhr review will be performed and updated at that time. A query of the trackwise complaints database for the timeframe of 12 months (from 06nov2014 to 06nov2015) was performed using the keywords? Flowable wound matrix? That also include the keywords? Pain? Or? Ambulation.? This complaint is associated with flowable wound matrix. There were approximately (b)(4) of these products sold in the past year. As per the trending query, there was (1) complaint identified related to flowable. Therefore; the calculated complaint rate is (b)(4). Conclusion: the root cause is undetermined. While possible hazards were identified in the mdha using keywords from the complaint, no lot number was provided for dhr review. Integra lifesciences has process steps and testing in place to mitigate risk and is dedicated to manufacturing safe and effective product. As described in the trending section, no trend has been identified. The original complaint alleged the care of this patient involved negligent acts and/or omissions that did not comply with the? Standard of care.?
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1121308-2015-00024 |
| MDR Report Key | 5240763 |
| Date Received | 2015-11-20 |
| Date of Report | 2015-10-27 |
| Date Mfgr Received | 2015-12-21 |
| Date Added to Maude | 2015-11-20 |
| 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 | 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 | FLOWABLE WOUND MATRIX - UNSPECIFIED |
| Generic Name | N/A |
| Product Code | KGN |
| Date Received | 2015-11-20 |
| Catalog Number | XXX-FLOWABLE |
| 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 | 1. Required No Informationntervention; 2. Deathisabilit | 2015-11-20 |