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 2018-04-20 for XENMATRIX AB 1151935 manufactured by Davol Inc., Sub. C.r. Bard, Inc..
[106010568]
There is no connection that can be made at this time between the reported postoperative complication (right sided pain near incision) and any problem / malfunction with the davol device used to treat the patient. No action was taken and the ae is reported to have resolved. Postoperative pain is a known inherent risk of surgery and the drains were still in place at the time the pain was reported. 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 based on stability data. As such the device was implanted within the current shelf life period and this would not be a contributory factor to the patient's 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
[106010569]
It was reported that a patient who is part of a clinical study had experienced postoperative pain. On (b)(6) 2016 the subject patient underwent an exploratory laparotomy, lysis of adhesions, excision of suture granulomata with implant of a xenmatrix ab graft. At the time of the procedure, the patient had a bacterial infection of the wound in which cultures revealed staphylococcus aureus. The procedure was not delayed for treatment. A recto-rectus with component separation technique was performed using an open method for cst. The xenmatrix ab was trimmed and a 5cm graft overlap was maintained around the hernia defect. The hernia was located in the epigastric area with suture fixation of the graft. The midline fascia and skin were completely closed. Drains were inserted in the right lower quadrant and the left lower quadrant. On (b)(6) 2016 the subject patient was discharged from the hospital. On (b)(6) 2017 subject patient presented with "intermittent stabbing, postoperative pain in the right side near incision. " the right lower quadrant drain was removed during this visit. On (b)(6) 2017 the left lower quadrant drain was removed. The ae is indicated as resolved on (b)(6) 2017. This adverse event was assessed by the clinician as a grade1, mild ae that is possibly related to the device and possibly related to the procedure. No action was taken and the pain has resolved.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1213643-2018-01155 |
| MDR Report Key | 7446173 |
| Report Source | HEALTH PROFESSIONAL,OTHER,STU |
| Date Received | 2018-04-20 |
| Date of Report | 2018-04-20 |
| Date of Event | 2017-01-06 |
| Date Mfgr Received | 2018-03-29 |
| Device Manufacturer Date | 2015-03-12 |
| Date Added to Maude | 2018-04-20 |
| 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 | 2018-04-20 |
| Model Number | NA |
| Catalog Number | 1151935 |
| Lot Number | HUZA1974 |
| Device Expiration Date | 2015-07-28 |
| 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 | 2018-04-20 |