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 2018-06-21 for XENMATRIX AB 1152025 manufactured by Davol Inc., Sub. C.r. Bard, Inc..
[111944273]
Based on the information provided we are unable to determine to what extent the xenmatrix ab may have caused or contributed to the patient's partial bowel obstruction. The patient has a complicated medical history which includes, multiple small bowel obstructions and multiple abdominal surgeries. At this time no conclusion can be made. A review of the manufacturing records was performed and found that the lot was manufactured to specification. Should additional information be obtained, a supplemental emdr will be submitted. Note, emdr's were previously submitted to document the other reported adverse events associated to this patient. Note: 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
[111944274]
The following was reported and is associated with a clinical study. On (b)(6) 2016 at the time of implant the hernia site wound was classified as a class 1 (clean) with no existing infection. The index procedure included a partial mesh (unknown) excision and extensive lysis of adhesions. The unknown mesh was removed due to the extent of the adhesions. The existing hernia repair was performed with a retro-rectus technique without component separation. The hernia defect was measured with a length of 25cm and width of 14cm. The xenmatrix ab graft was trimmed prior to placement. There was a graft overlap of at least 5cm around the hernia defect. The hernia location is listed to have encompassed the subxiphoid, epigastric, umbilical and infraumbilical area. The graft was suture fixated. A surgical drain was placed in the right lower quadrant, recto-rectus space. Following the implant procedure during the time period of (b)(6) 2016 - (b)(6) 2016 the patient was treated for multiple adverse events (dehydration, seroma, abdominal pain, diarrhea) these events have resolved. The patient was hospitalized (b)(6) 2018-(b)(6) 2018 and diagnosed with ileal diverticulitis. This event was assessed as not related to the study device and not related to the procedure. As reported this event has resolved. The patient was hospitalized on (b)(6) 2018-(b)(6) 2018, diagnosed with a partial bowel obstruction. This event has been assessed as possibly device related and possibly procedure related. The patient was treated with a nasogastric tube and gastrografin and the event resolved.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1213643-2018-02099 |
| MDR Report Key | 7626759 |
| Report Source | HEALTH PROFESSIONAL,OTHER,STU |
| Date Received | 2018-06-21 |
| Date of Report | 2018-06-21 |
| Date Mfgr Received | 2018-06-05 |
| Device Manufacturer Date | 2016-01-29 |
| Date Added to Maude | 2018-06-21 |
| 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 | 2018-06-21 |
| Model Number | NA |
| Catalog Number | 1152025 |
| Lot Number | HUZL0467 |
| Device Expiration Date | 2017-12-28 |
| 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 | 2018-06-21 |