MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2017-10-17 for XENMATRIX AB 1151520 manufactured by Davol Inc., Sub. C.r. Bard, Inc..
[89752372]
As reported the expired device was implanted in error. A review of our records shows that the device was well within the date of expiry (08/28/2017) when provided to the facility in 2015. This event is confirmed for use related. The ifu instructs the user to inspect the package prior to use. The information provided by bard represents all of the known information at this time. Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard. Remains implanted.
Patient Sequence No: 1, Text Type: N, H10
[89752373]
It was reported that an expired xenmatrix ab graft was placed in a patient in error. As reported the surgeon elected to leave the device in place. The contact states the surgeon performed a visual assessment of the graft prior to implanting. To date there has been no reported injury to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1213643-2017-00689 |
| MDR Report Key | 6956382 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-10-17 |
| Date of Report | 2017-10-17 |
| Date Mfgr Received | 2017-09-22 |
| Device Manufacturer Date | 2015-09-19 |
| Date Added to Maude | 2017-10-17 |
| 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 | LAURA SUNDBERG |
| Manufacturer Street | 100 CROSSINGS BLVD. |
| Manufacturer City | WARWICK RI 02886 |
| Manufacturer Country | US |
| Manufacturer Postal | 02886 |
| Manufacturer Phone | 4018258462 |
| Manufacturer G1 | BARD SHANNON LIMITED -3005636544 |
| Manufacturer Street | SAN GERONIMO INDUSTRIAL PARK LOT #1, ROAD #3, KM 79.7 |
| Manufacturer City | HUMACAO PR 00791 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 00791 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | XENMATRIX AB |
| Generic Name | PORCINE SURGICAL MESH |
| Product Code | PIJ |
| Date Received | 2017-10-17 |
| Model Number | NA |
| Catalog Number | 1151520 |
| Lot Number | HUZH0392 |
| Device Expiration Date | 2017-08-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DAVOL INC., SUB. C.R. BARD, INC. |
| Manufacturer Address | 100 CROSSINGS BLVD. WARWICK RI 02886 US 02886 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-10-17 |