MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2016-08-16 for IDRT SINGLE LAYER (INTL) 2X2 SINGLE 62021 manufactured by Integra Lifesciences Corporation.
[52279052]
It was reported the delivery has been shipped incorrectly. The purchase order had 2? 20x25cm ordered but we received 2? 5x5cm. The patient was anesthetized and already debrided. It was reported that although the device was not in contact with the patient, the patient was injured. The event led to an increase of surgery time of 1 hour. ? The product could not properly be used because it is too small in size.? It was later reported the patient underwent reconstructive surgery. The surgeon did not use the 5x5cm sheets, integra sent the wrong size. The surgeon ordered 2 of the 20x25cm sheets. The surgeon completed the procedure by closing the wound and no sheet was applied. ? I guess that they used npwt (negative pressure wound therapy).? The surgeon did not cancel the surgery because they looked at the carton but did not double check the delivered sizes (inside the carton). The surgeon proceeded with the debridement. The surgeon feels the fact that the patient was under anesthesia and underwent the debridement prior to the discovery of the issue, this constitutes a patient injury.
Patient Sequence No: 1, Text Type: D, B5
[54429832]
Additional request made 18aug2016: "? Does it mean that the carton mentioned that the product is idrt sl 20x25 cm although inside there was idrt sl with 5x5 cm? " complementary information received on 19 august 2016: "cs only saw the carton from the delivery, the cooling box, and they thought that the right product was there. But when they opened the box after preparing the patient they realized that the size was 5x5 cm. " additional information received 9sep2016: the product was used on the patient? S back. The patient is male. Information repeated from earlier reporting: the surgery was delayed 1 hour but there were no adverse consequences for the patient. They closed the wound with a dressing and completed the surgery. The patient recovered in the icu. Grafting with integra? Should be done the next week.?
Patient Sequence No: 1, Text Type: N, H10
[67464730]
Integra has completed their internal investigation on january 25, 2017: investigation ensures that all lots are manufactured, packaged and tested as per applicable sop/production records instructions. Additionally, this complaints is not associated with an ability to use device due to device failure. This complaint is related to wrong product size delivery, and no cross-check of the delivery by customer to confirm accuracy of product sizes before usage, which caused delay in surgery. Additionally, a 12 month query of nc log showed that there were no ncs associated with skin lots released related to the process steps. A query of capa log revealed no capa initiated for idrt-sl related to wrong product shipment or skin delivery issues, as well as patient surgery delay, in the past 12 months.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1121308-2016-00016 |
| MDR Report Key | 5880906 |
| Report Source | DISTRIBUTOR |
| Date Received | 2016-08-16 |
| Date of Report | 2016-08-05 |
| Date of Event | 2016-08-05 |
| Date Mfgr Received | 2017-01-25 |
| Date Added to Maude | 2016-08-16 |
| 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 SINGLE LAYER (INTL) 2X2 SINGLE |
| Generic Name | IDRT |
| Product Code | MGR |
| Date Received | 2016-08-16 |
| Catalog Number | 62021 |
| Lot Number | 105A00338876 |
| 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 CORPORATION |
| Manufacturer Address | 105 MORGAN LANE 105 MORGAN LANE PLAINSBORO NJ 08536 US 08536 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-08-16 |