MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,other report with the FDA on 2016-09-23 for XENMATRIX AB 1151015 manufactured by Davol Inc., Sub. C.r. Bard, Inc..
[55468641]
Based on the information available at this time, no conclusions can be made. The patient's attorney did not allege a specific device failure or patient injury and medical records were limited to the patient's implant op report and hospital billing page only. A review of the manufacturing records is not possible as product identifiers were not provided. If additional information is obtained, a supplemental mdr 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
[55468642]
The following is based on a review of limited medical records and the attorney's legal claim provided to davol by the patient's attorney: on (b)(6) 2014: the patient was diagnosed with uterine prolapse, stress urinary incontinence, cystocele, full thickness rectal prolapse and underwent a three part procedure which included a laparoscopic assisted hysterectomy, bilateral salpingo-oophorectomy, vaginal polypoid lesion removal, implant of a non bard/davol "mini-arc" pubovaginal sling, anterior repair and a robotic assisted ventral rectopexy with implant of a bard/davol "xenmatrix ". Per the operative details, "once we got down to the anorectal ring it was felt the dissection was as low as it could go so an antibiotic impregnated xenmatrix mesh was brought onto the field and hydrated. This was cut in a 4 x 15 cm piece. This was inserted through the operating assistant trocar. This was secured to the anterior rectal wall with two interrupted 2-0 vicryl sutures. Vicryl sutures were placed up along the anterior rectal wall approx every 2-3 cm securing the mesh to the anterior rectal wall. A rectopexy was then performed using pds suture to the sacral promontory, securing the mesh. The posterior vaginal cuff was secured down to the mesh using vicryl with a lapra tie. " the patient's attorney alleges unspecified adverse patient outcomes associated with use of device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1213643-2016-00449 |
| MDR Report Key | 5973201 |
| Report Source | CONSUMER,OTHER |
| Date Received | 2016-09-23 |
| Date of Report | 2018-04-30 |
| Date of Event | 2016-03-14 |
| Date Mfgr Received | 2018-04-09 |
| Date Added to Maude | 2016-09-23 |
| 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 | FRANCESCA SANTAMARIA |
| Manufacturer Street | 100 CROSSINGS BLVD. |
| Manufacturer City | WARWICK RI 02886 |
| Manufacturer Country | US |
| Manufacturer Postal | 02886 |
| Manufacturer Phone | 4018258538 |
| 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 | 2016-09-23 |
| Catalog Number | 1151015 |
| 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. Hospitalization; 2. Other; 3. Required No Informationntervention | 2016-09-23 |