MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2017-01-04 for OMNIGRAFT AND DISPOSABLE STAPLER KIT 4CM X 4CM DFU4041S manufactured by Integra Lifesciences Corporation.
[63827684]
It was reported the patient was implanted with the product 4 days past it? S expiration date. It was reported there was no patient injury alleged, no revision or medical intervention required, and no surgery delay.
Patient Sequence No: 1, Text Type: D, B5
[67690642]
Integra has completed their internal investigation on february 4, 2017. The investigation included: methods: review of device history records. Review of complaints history. Results: the failure is unconfirmed as there was no product returned for this complaint. Failure analysis could not be performed. The omnigraft was used during surgery, and is implanted in the patient, therefore will not be returned for failure analysis. Dhr review; based on the dhr review conducted, there is no indication that the production process may have contributed to this complaint. All test results passed the procedural specifications, and there were no defects observed related to error in expiry or releasing/distributing expired material. Complaints history; a query was performed using the keywords? Expir? And? Expire? For complaints issued from 07-dec-2015 to 07-dec-2016 and no additional complaints were found related to omnigraft products. Another query was performed searching for complaints related to lot 105ka0352098; no additional complaints were found. (b)(4). Conclusion: per the complaint background, the patient was implanted with omnigraft 4 days past it? S labeled expiry. The device is still in contact with the patient. There were no adverse events/patient injury reported, nor there were any revisions required or a delay in surgery noted for this event. According to ott sales representative, no one at the hospital checked the expiration date on labeling before usage. He mentioned that the product was brought into the hospital already expired, so it was an oversight by the sales representative. This is not a consignment product. Rdc reworked lot 105ka0352098 as the lot expiry was extended from 6 months to 12 months from the date of packaging. This lot was packaged in may 2016. Therefore, the expiry was extended to 31-may-2017. The reworked units were released on 03-nov-2016, and this complaint was brought to awareness on 07-dec-2016. Divisional regulatory sent an expiry extension letter to this customer after this complaint was initiated, indicating that the shelf life of the reported product lot was extended from 30-nov-2016 to 31-may-2017 because during the planned periodic review of stability data, the next stability time point requirements for this product were met. The field staff was not aware of an expiration date extension prior to this complaint, nor instructed on how to manage product already in the field with the initial expiration date indicated. The expiration date communication through product labeling is considered sufficient to ensure the hospital staff knows the date and that it is not used post expiration, and the shelf life extension stability study as well as the letter provided by regulatory support the product expiry until may 2017.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1121308-2016-00022 |
| MDR Report Key | 6221402 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-01-04 |
| Date of Report | 2016-12-07 |
| Date of Event | 2016-12-05 |
| Date Mfgr Received | 2017-02-04 |
| Date Added to Maude | 2017-01-04 |
| 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 | OMNIGRAFT AND DISPOSABLE STAPLER KIT 4CM X 4CM |
| Generic Name | INTEGRA OMNIGRAFT DERMAL REGENERATION MATRIX |
| Product Code | MDD |
| Date Received | 2017-01-04 |
| Catalog Number | DFU4041S |
| Lot Number | 1646253 |
| 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 | 2017-01-04 |