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 2018-02-15 for XENMATRIX AB 1151935 manufactured by Davol Inc., Sub. C.r. Bard, Inc..
[100127284]
There is no connection that can be made at this time between the reported post-operative complications and any problem with the bard/davol device used to treat the patient. Information regarding the pre-implant condition of the patient and the implant procedure are limited at this time. Our records show the lot was manufactured and sterilized per procedure with no anomalies noted. Based on the limited information provided at this time, no conclusions can be made. Should additional information be provided, a supplemental emdr will be submitted. 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.
Patient Sequence No: 1, Text Type: N, H10
[100127285]
It is reported that on (b)(6) 2018 the patient underwent a "wound closure with mesh bridge" using a xenmatrix ab graft. As reported, the following day the patient's wound dehisced and allegedly the xenmatrix ab graft was completely dissolved. As reported, the xenmatrix ab graft was not implanted into an infected wound.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1213643-2018-00290 |
| MDR Report Key | 7272637 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-02-15 |
| Date of Report | 2018-02-15 |
| Date of Event | 2018-01-24 |
| Date Mfgr Received | 2018-01-24 |
| Device Manufacturer Date | 2016-02-29 |
| Date Added to Maude | 2018-02-15 |
| 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 | 2018-02-15 |
| Model Number | NA |
| Catalog Number | 1151935 |
| Lot Number | HUAN0730 |
| Device Expiration Date | 2018-01-28 |
| 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 | 1. Required No Informationntervention | 2018-02-15 |