MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2017-03-30 for IDRT-TS (INTL) SINGLE 4X5 84051 manufactured by Integra Lifesciences Corporation.
[71334765]
Integra has completed their internal investigation on march 27, 2017. The investigation included: methods: review of device history records. Review of complaints history. Results: the failure is unconfirmed. No failure analysis could be performed as the product was used on the patient during surgery, and has not returned. Dhr review; the nc/event log and batch record were reviewed for any events related to the lots of the components used to manufacture the product. Any events or ncs related to the parent dispersion lot or the reported finished goods lot of any time period was considered. No events or ncs were found for this lot or it? S component lots related to skin visual appearance defects. Complaints history; a query of the complaint database for the timeframe of 12 months ((b)(6) 2016-(b)(6) 2017) was performed using the individual keywords:? Skin? And? Thick? Or? Thin? Or? Uneven?. No other complaints were found. Conclusion: the root cause is likely user misinterpretation of the required thickness range for idrt. Based on the complaint background provided, review of the batch production records and trending, risk analysis, and the complaint type, it can be determined that the doctor noticed a visual difference in the thickness of both idrt sheets when compared, but based on the manufacturing process of the complaint lot, no failure occurred. Company sop defines uneven or descending thickness of sponge from end to end > 2:1 ratio as a defect. Manufacturing performs 100% visual inspection of all sponges per sop to ensure each device meets this criterion. If an out of specification thickness was identified with any device during inspection, the impacted device would be rejected. Thickness does inherently vary for the coated skin products, but the thickness of both the uncoated product and silicone is checked/documented in process and was within the acceptable range. Products are only released based on finished goods release testing and batch record criteria.
Patient Sequence No: 1, Text Type: N, H10
[71334766]
2 of 2 reports - other mfg report number: 1121308-2017-00004. It was reported a thickness issue on two idrt layers: one is thicker than and the other is thinner than usual. The customer was not able to confirm which device of the two was thicker or thinner, but when the customer compared the two devices they were both visually different in thickness. No patient injury reported and the event did not lead to surgical delay.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1121308-2017-00005 |
| MDR Report Key | 6445677 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2017-03-30 |
| Date of Report | 2017-02-10 |
| Date Mfgr Received | 2017-06-29 |
| Device Manufacturer Date | 2016-06-01 |
| Date Added to Maude | 2017-03-30 |
| 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 SONIA IRIZARRY |
| 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 4X5 |
| Generic Name | IDRT-TS |
| Product Code | MDD |
| Date Received | 2017-03-30 |
| Returned To Mfg | 2017-04-17 |
| Catalog Number | 84051 |
| Lot Number | 105NKA352492 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2017-03-30 |