MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,other report with the FDA on 2018-04-13 for XENMATRIX 1151015 manufactured by Davol Inc., Sub. C.r. Bard, Inc..
[105413175]
There is no connection that can be made at this time between the reported post-operative complications and the bard/davol xenmatrix device used to treat the patient. The patient's attorney has alleged "a non-functional hard ball of mesh believed to be from the xenmatrix mesh" was discovered during an exploratory laparotomy on (b)(6) 2016, however it is unclear if the device was explanted at that time therefore we are not reporting it as an explanted device. No sample was returned for evaluation and medical records are not available. No lot number has been provided; therefore a review of the manufacturing records is not possible at this time. Adhesions and hernia recurrence are a known inherent risks of surgery and are listed in the instructions-for-use as possible complications. Based on the limited information provided and the reported patient's pre-existing conditions, no conclusions can be made between the reported post-operative complications and the bard/davol xenmatrix device. 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. Not returned.
Patient Sequence No: 1, Text Type: N, H10
[105413176]
The patient's attorney has alleged that: on (b)(6) 2016 - patient underwent a laparoscopic colectomy and ileostomy. Following the procedure, the patient quickly developed complications, including a bowel obstruction, sepsis and a hernia. On (b)(6) 2016 - the patient's doctor preformed an operation to relive the obstruction and repair the hernia using an unspecified bard/davol xenmatrix biological mesh. On (b)(6) 2016 - the patient was released from the hospital and continued to suffer post-operative complications caused by the dysfunctional ileostomy. On (b)(6) 2016 - the patient was readmitted with severe hypotensive episode, acute renal injury, high output ileostomy, and a parastomal hernia. On (b)(6) 2016 - the patient was discharged following treatment for events of (b)(6) 2016. Over the course of several months, the patient developed multiple complications secondary to dysfunctional ileostomy. On (b)(6) 2016 - the patient was readmitted where she underwent exploratory laparotomy for parastomal hernia and malfunctioning ileostomy. During the exploratory laparotomy, "a nonfunctional, hard ball of mesh, believed to be from the bard/davol xenmatrix mesh that was used during the (b)(6) 2016 procedure, was discovered in the patient's abdomen and the mesh had adhered to the patient's bowel. " on (b)(6) 2016 - the patient was discharged following surgical procedure on (b)(6) 2016, but continued to experience severe and persistent abdominal pain. On (b)(6) 2017 - the patient was admitted with increasing abdominal pain and was advised following evaluation that nothing further could be done to assist her. On (b)(6) 2018 - the patient was admitted where she underwent parastomal hernia repair and has since experienced an improved condition. As reported by the patient's attorney the patient "suffered injuries and damages, including past future pain and suffering. " the patient's attorney alleges that "the defective xenmatrix was a direct, proximate and producing cause of the patients injuries and damages" and further alleges that the patient "suffered grievous bodily injury when treated using xenmatrix.. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1213643-2018-01074 |
| MDR Report Key | 7429013 |
| Report Source | CONSUMER,OTHER |
| Date Received | 2018-04-13 |
| Date of Report | 2018-11-12 |
| Date of Event | 2016-09-29 |
| Date Mfgr Received | 2018-10-17 |
| Date Added to Maude | 2018-04-13 |
| 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 |
| Reporter Occupation | ATTORNEY |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | STEVEN FIGUEROA |
| Manufacturer Street | 100 CROSSINGS BLVD. |
| Manufacturer City | WARWICK RI 02886 |
| Manufacturer Country | US |
| Manufacturer Postal | 02886 |
| Manufacturer Phone | 4018258605 |
| 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 |
| Generic Name | SURGICAL MESH |
| Product Code | PIJ |
| Date Received | 2018-04-13 |
| Model Number | NA |
| Catalog Number | 1151015 |
| Lot Number | HUZB1430 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2018-04-13 |