MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-03-09 for FLOWABLE WOUND MATRIX FWD301 manufactured by Integra Lifesciences Corporation.
[69854793]
To date the device involved in the reported incident has not been received for evaluation. An investigation has been initiated based on the reported information.
Patient Sequence No: 1, Text Type: N, H10
[69854794]
It was reported that when the flowable wound matrix was sold, was expired. The expiration date november 30, 2016, sold to account january 2, 2017. Additional information has been requested.
Patient Sequence No: 1, Text Type: D, B5
[74608612]
Additional information received from the sales rep on april 11, 2017; "this product was not used in a patient. I meant to write these off as samples not used clinically but made a mistake when closing out the charge sheet in (b)(6). " integra has completed their internal investigation on april 16, 2017. The investigation included: methods: review of device history records. Review of complaints history. Results: the failure is unconfirmed, as the flowable product was not returned back for failure analysis. Dhr review; dhr review confirms that flowable wound matrix 3 cc lot 105n00325986 expired on 11-2016. The manufacturing month/year of this lot is may/2015 (calculated from the date of sterilization) and the expiry is november/2016. There is no indication that the production process at integra could have contributed to this complaint. Complaints history; a trackwise query was performed using the keywords? Expir? And? Expire? For complaints issued within from 24-feb-2016 through 24-feb-2017 and no additional complaints were found related to flowable products. A lot query was performed for the 105 syringe lot 105n00325986, using the trackwise complaints database. No additional complaints were found for this lot. There have been approximately (b)(4) flowable units sold in the past 12 months. As per the trending queries, there has been only (b)(4) complaint identified for expired product sold (current complaint) from the flowable product family. Therefore, the calculated complaint rate is (b)(4)%. Conclusion: (root/cause): the root cause of this complaint is human error. The most probable cause of this complaint is the error in the charge sheet that the sales specialist completed. This was indicated by the sales individual as stated in the additional information of the complaint. The expiration date of the flowable unit was evident and meant to be charged as clinical samples. In the case that they were sold, the sales specialist likely did not verify the expiry prior to distributing it to the customer, as the product unit was documented as sold to the customer on (b)(6) 2017, per the complaint background; and the product expired on nov-2016.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1121308-2017-00003 |
| MDR Report Key | 6390982 |
| Date Received | 2017-03-09 |
| Date of Report | 2017-02-24 |
| Date Mfgr Received | 2017-04-11 |
| Device Manufacturer Date | 2015-05-01 |
| Date Added to Maude | 2017-03-09 |
| 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 | FLOWABLE WOUND MATRIX |
| Generic Name | FWD |
| Product Code | KGN |
| Date Received | 2017-03-09 |
| Catalog Number | FWD301 |
| Lot Number | 111000177058 |
| 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 | 2017-03-09 |