MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,other report with the FDA on 2018-11-02 for XENMATRIX AB UNKAA105 manufactured by Davol Inc., Sub. C.r. Bard, Inc..
[126015370]
At this time no conclusions can be made. No lot number has been provided therefore a review of the manufacturing records is not possible at this time. The patient's attorney alleges unspecified injuries; however, no details have been provided regarding the nature of the injury and for the additional surgery for explant of the device. No medical records have been provided. Information is limited at this time. Should additional information be provided a supplemental emdr will be submitted. Not returned.
Patient Sequence No: 1, Text Type: N, H10
[126015371]
The following was alleged by the patient's attorney: (b)(6) 2015:the patient was diagnosed with a ventral hernia and underwent ventral hernia repair with a bard/davol xenmatrix ab surgical graft product. In the months following the (b)(6) 2016 explant of the bard/davol xenmatrix ab surgical graft, the patient continued to experience chronic abdominal pain, and further experiences several medical issues in which the patient is currently seeking additional medical treatments for. As a result of having the product (bard/davol xenmatrix ab surgical graft), the patient has experienced significant mental and physical pain and suffering and mental anguish, has sustained permanent injury, has undergone medical treatment and/or corrective surgery hospitalization and will likely undergo further medical treatment and procedures. It is alleged that the bard/davol xenmatrix ab surgical graft product is defective.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1213643-2018-03830 |
| MDR Report Key | 8034996 |
| Report Source | CONSUMER,OTHER |
| Date Received | 2018-11-02 |
| Date of Report | 2018-11-02 |
| Date of Event | 2016-10-20 |
| Date Mfgr Received | 2018-10-10 |
| Date Added to Maude | 2018-11-02 |
| 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 | JAN LING |
| Manufacturer Street | 100 CROSSINGS BLVD. |
| Manufacturer City | WARWICK RI 02886 |
| Manufacturer Country | US |
| Manufacturer Postal | 02886 |
| Manufacturer Phone | 8015652663 |
| 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 | SURGICAL MESH |
| Product Code | PIJ |
| Date Received | 2018-11-02 |
| Model Number | NA |
| Catalog Number | UNKAA105 |
| Lot Number | NI |
| 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; 2. Deathisabilit | 2018-11-02 |