MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign report with the FDA on 2017-07-17 for IDRT-TS (INTL) SINGLE 4X5 84051 manufactured by Integra Lifesciences Corporation.
[80219444]
Integra has completed their internal investigation on july 29, 2017. Results: evaluation of returned device; the pictures provided show that there is a fold in the skin unit. Therefore, the failure is confirmed even though the product was not returned back to cmc for failure analysis. Dhr review; idrt-ts (international) lot 105nb0344891 was not folded during the packaging process; this shows that the lot was placed into the pe sheets correctly and that there were no folds in the skin during packaging. Complaints history; there have been approximately (b)(4) idrt-ts family units sold in the past 12 months (may 2016 to may 2017). As per the trending queries, there has been only one (1) complaint identified for folded product sold (current complaint) from the skin product family. Therefore, the calculated complaint rate is (b)(4). Conclusion: the root cause of this complaint is most likely due to handling. The? Fold/bent? Most likely occurred after the packaging process. There are multiple processes after packaging that require manual handling: shipping to the sterilizer, back from sterilizer, at the distribution center, to the customer, etc. This was also confirmed as the most likely cause by the production supervisor at integra. Integra has sops in place to ensure that skin is carefully handled during processing, and operators are trained on these sops. These sops are considered sufficient for their intended purposes. With the procedures in place, it is most likely that the mishandling occurred after shipment from integra.
Patient Sequence No: 1, Text Type: N, H10
[80219445]
It was reported that after the skin incision, they opened the packaging and the product was bent / folded inside the internal packaging. As only one unit was in the or, they had to use it. They used only the part which was not bent / folded by cutting it at the proper size. No patient harm and the event lead to 10 minutes surgical delay.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1121308-2017-00010 |
| MDR Report Key | 6716751 |
| Report Source | FOREIGN |
| Date Received | 2017-07-17 |
| Date of Report | 2017-05-15 |
| Date Mfgr Received | 2017-06-29 |
| Date Added to Maude | 2017-07-17 |
| 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 | 2017-07-17 |
| Catalog Number | 84051 |
| Lot Number | 105NB0344891 |
| 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 | 2017-07-17 |