MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign report with the FDA on 2018-07-19 for IDRT-TS (INTL) SINGLE 8X10 88101 manufactured by Integra Lifesciences Corporation.
[114695198]
The failure is unconfirmed, as the idrt-ts product was not returned back for failure analysis. Dhr review confirms that idrt-ts lot 2547029 was not folded during the packaging process. Therefore, the failure is unconfirmed as the product was used during surgery and not returned. The root cause of this complaint is most likely due to handling. It is difficult to know when in the process (during the shipping to the sterilizer, back from sterilizer, at the distribution center, etc. ) the folding might have occurred. However, the? Fold/bent? Most likely occurred after the packaging process.
Patient Sequence No: 1, Text Type: N, H10
[114695199]
It was noticed that the idrt was folded when opening and could not be applied correctly. They have to cut the folded part and apply the remaining part. The product was in contact with the patient; however it is unknown if there was any patient injury or if the event lead to a significant increase of surgery time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1121308-2018-00026 |
| MDR Report Key | 7701944 |
| Report Source | FOREIGN |
| Date Received | 2018-07-19 |
| Date of Report | 2018-07-03 |
| Date Mfgr Received | 2018-07-03 |
| Date Added to Maude | 2018-07-19 |
| 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-TS (INTL) SINGLE 8X10 |
| Generic Name | IDRT-TS |
| Product Code | MDD |
| Date Received | 2018-07-19 |
| Catalog Number | 88101 |
| Lot Number | 2547029 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| 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 | 2018-07-19 |