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 2018-08-17 for XENMATRIX AB 1151015 manufactured by Davol Inc., Sub. C.r. Bard, Inc..
[117562544]
Based on the information provided we are unable to determine to what extent, if any, the xenmatrix ab graft may have caused or contributed to the abdominal pain and diarrhea. This is a patient with a complicated medical / surgical history which includes laparoscopic colectomy, lysis of adhesions, rigid sigmoidoscopy and ileorectal anastomosis, colectomy and ileorectal anastomosis, and a loop ileostomy takedown and primary small bowel anastomosis, in the area of the repair. The clinician has assessed this adverse event as possibly related to the study device and possibly related to procedure. It is also possible that the adverse event is related to a patient comorbidity and not the study device. No action was taken with the study device and the adverse event is reported to have resolved. A review of the manufacturing records was performed and found that the lot was manufactured to specification. Should additional information be reported, 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
[117562545]
It was reported that a patient who is part of a clinical study had experienced pain and diarrhea. On (b)(6) 2017 - the patient underwent a primary incisional infraumbilical hernia repair with implant of the xenmatrix ab graft. Intraperitoneal without component separation technique was used. The xenmatrix ab graft was not trimmed and a 5mm graft overlap was maintained around the hernia defect. On (b)(6) 2018 - the patient was assessed to have a clear and clean incision, no erythema and no recurrent hernia. On (b)(6) 2018 - the patient was assessed to have a well healed incision and no evidence of a hernia. On (b)(6) 2018 - the patient was hospitalized for abdominal pain and diarrhea. She was given iv fluids and pain medication. On (b)(6) 2018 - the patient was discharged with a status of recovered / resolved. This event has been assessed by the clinician as severe, possibly related to the study device and possibly related to be implant procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1213643-2018-02811 |
| MDR Report Key | 7793820 |
| Report Source | HEALTH PROFESSIONAL,OTHER,STU |
| Date Received | 2018-08-17 |
| Date of Report | 2018-08-17 |
| Date of Event | 2018-07-17 |
| Date Mfgr Received | 2018-07-26 |
| Device Manufacturer Date | 2017-06-07 |
| Date Added to Maude | 2018-08-17 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 2018-08-17 |
| Model Number | NA |
| Catalog Number | 1151015 |
| Lot Number | HUBR0416 |
| Device Expiration Date | 2019-04-28 |
| 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. Hospitalization; 2. Required No Informationntervention | 2018-08-17 |