MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,other,stu report with the FDA on 2018-04-04 for XENMATRIX AB 1151928 manufactured by Davol Inc., Sub. C.r. Bard, Inc..
[104406368]
There is no connection that can be made at this time between the reported postoperative complication (mild pain) and any problem / malfunction with the davol device used to treat the patient. Per the surgeon the pain is most likely attributable to the muscle release that was done as part of the hernia repair. Based on the information provided a definitive conclusion cannot be made. It was noted that the device in question was implanted after the labeled expiration date. Since the manufacture of this lot the shelf life for the xenmatrix ab graft has been extended to 24 months. As such the device was implanted within the current expiration period and this would not be a contributory factor to the patient postoperative complications. Should additional information be obtained, 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. Remains implanted.
Patient Sequence No: 1, Text Type: N, H10
[104406369]
It was reported that a patient who is part of a clinical study is experiencing mild postoperative pain. On (b)(6) 2016 - the patient underwent implant of the xenmatrix ab mesh, during a complex multi-part procedure including lysis of adhesions to remove bowel obstruction, excision of mass, removal of an unknown synthetic previously placed mesh and debridement. The procedure was performed retro-rectus without component separation technique. The size of the hernia defect was 26cm in length and 12cm in width. As reported, it was necessary to trim the xenmatrix ab graft and there was a 5cm graft overlap maintained around the hernia defect. The hernia location was midline and involved the umbilical, suprapubic, epigastric and infraumbilical space. The perimeter of the mesh was sutured with long-term absorbable monofilament with 7 fixation points. The midline fascia and skin were completely closed. Three drains were inserted in the retro-rectus left lower quadrant, subcutaneous right upper quadrant and the subcutaneous left upper quadrant. On (b)(6) 2018 - the patient present for visit and was asymptomatic. There was no evidence of hernia or recurrence and the patient reported mild right sided pain, which has been present and unchanged since operation. The patient continues to wear abdominal binder as this helps with her mild pain. Per the surgeon the pain is most likely attributable to the muscle release that was done as part of the hernia repair. The patient adverse event of right sided pain has been reported and assessed as possibly device related "as we can't completely rule this out" and definitely procedure related. As reported the patient is "doing great and continues to wear the abdominal binder. " no additional treatment has been reported. The outcome is reported as recovering/resolving.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1213643-2018-00895 |
| MDR Report Key | 7397526 |
| Report Source | HEALTH PROFESSIONAL,OTHER,STU |
| Date Received | 2018-04-04 |
| Date of Report | 2018-04-04 |
| Date of Event | 2016-08-17 |
| Date Mfgr Received | 2018-03-15 |
| Device Manufacturer Date | 2015-03-30 |
| Date Added to Maude | 2018-04-04 |
| 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 | 2018-04-04 |
| Model Number | NA |
| Catalog Number | 1151928 |
| Lot Number | HUZB1913 |
| Device Expiration Date | 2015-08-28 |
| 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 | 2018-04-04 |