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 2017-01-16 for IDRT-TS (INTL) SINGLE 8X10 88101 manufactured by Integra Lifesciences Corporation.
[65027970]
Integra completed its internal investigation 21dec2016. The investigation included: method: review of device history records; review of complaint management database for similar complaints. Results: the reported product lot associated with this complaint for idrt-ts (intl) single 8x10 is lot# 105nb0315607. This finished goods product lot stems from parent dispersion lot# 105n00316562. The manufacture date for this lot is september 2014 and date of expiry is 30sep2016. Based on the dhr review conducted, there were no anomalies found within the batch record. All manufacturing steps and processes were followed and all testing met requirements per applicable procedures. A lot query was able to be performed. There were approximately(b)(4) 82 ce marked wound care product family units sold in the past 12 months prior to this complaint. There were (b)(4) complaints identified related to idrt graft loss or graft poor take. Calculated complaint rate is (b)(4). There were no complaints found for this lot. Conclusion: the root cause is undetermined. Dhr review did not find any anomalies within the batch record. All manufacturing steps and processes were followed and all testing met requirements per applicable procedures. There is no indication from the batch record review that the(b)(4) production process may have contributed to this complaint.
Patient Sequence No: 1, Text Type: N, H10
[65027971]
It was reported the product did not work. The patient had idrt and then graft. The skin graft has not been incorporated after the laying of the matrix. It was reported that although the device was in contact with the patient there was no patient injury alleged. It was reported the event did not lead to an increase of surgery time. It was reported the event occurred (b)(6) 2016.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1121308-2017-00001 |
| MDR Report Key | 6254658 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-01-16 |
| Date of Report | 2016-10-01 |
| Date of Event | 2016-06-01 |
| Date Mfgr Received | 2016-12-21 |
| Device Manufacturer Date | 2014-09-01 |
| Date Added to Maude | 2017-01-16 |
| 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 | IDRT-TS (INTL) SINGLE 8X10 |
| Generic Name | IDRT-TS |
| Product Code | MDD |
| Date Received | 2017-01-16 |
| Catalog Number | 88101 |
| Lot Number | 105NB0315607 |
| Device Expiration Date | 2016-09-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2017-01-16 |