MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2016-05-19 for XENMATRIX AB 1151935 manufactured by Davol Inc., Sub. C.r. Bard, Inc..
[45524621]
Based on the information provided the xenmatrix ab graft was placed in a grossly infected abdomen with bowel content draining from the wound. It appears that the reported "disintegration" of the graft may have been the result of placing the graft in a grossly infected environment. The warning section of the ifu states, "this device is not indicated for the treatment of infection. If an infection develops, treat the infection aggressively. " the precaution section states, "place device in maximum possible contact with healthy, well-vascularized tissue to promote cell ingrowth and tissue remodeling. " and "when unable to close skin over the xenmatrix ab surgical graft, ensure that the implant remains moist. Avoid drying of the implant through "continued suction devices" as this may negatively impact the performance of the implant. " a review of the manufacturing records was performed and found that the lot was manufactured to specification. Based on the information available at this time, no definitive conclusions can be made. 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. Remains implanted.
Patient Sequence No: 1, Text Type: N, H10
[45524622]
The following was reported to davol: on (b)(6) 2016 an obese patient with two grossly infected open areas on the abdomen underwent a procedure to explant two non davol mesh that had been implanted for approximately one year. As reported the infected areas never closed following the implant of the non davol mesh one year prior. At this time a xenmatrix ab was placed into the abdomen as an onlay. It is reported that the bacteria in the infected areas is believed to have been e. Coli as there was bowel content draining into the wound. Three days post repair, the xenmatrix ab was reported to have a large portion that had disintegrated. As reported, there was no adverse effect on the patient due to the graft disintegration. The remaining graft was not explanted and the surgeon is monitoring the patient at this time with no scheduled surgical intervention.
Patient Sequence No: 1, Text Type: D, B5
[45651452]
This is an addendum to the initial mdr to make corrections to the product classification code and to the 510(k) #.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1213643-2016-00216 |
| MDR Report Key | 5667216 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2016-05-19 |
| Date of Report | 2016-05-02 |
| Date of Event | 2016-05-02 |
| Date Mfgr Received | 2016-05-20 |
| Device Manufacturer Date | 2015-12-23 |
| Date Added to Maude | 2016-05-19 |
| 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 BERG |
| 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 | 2016-05-19 |
| Catalog Number | 1151935 |
| Lot Number | HUZK0574 |
| Device Expiration Date | 2017-11-30 |
| 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 | 2016-05-19 |