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 2018-04-17 for XENMATRIX AB 1153030 manufactured by Davol Inc., Sub. C.r. Bard, Inc..
[105710020]
There was no connection that can be made between the reported postoperative complication (seroma) and any problem with the xenmatrix ab graft used to treat the patient. The graft remains implanted. No definitive conclusion can be made at this time. Seroma formation is a known inherent risk of surgery and is identified in the adverse reaction section of the instructions-for-use as a potential complication. A review of the manufacturing records was performed and found that the lot was manufactured to specification. If additional information is provided, 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
[105710021]
It was reported that a patient who is part of a clinical study has been diagnosed with a seroma. On (b)(6) 2017 the subject patient underwent repair of a subxiphoid, epigastric hernia using a xenmatrix ab graft. Concomitant procedures were also performed at this time and included, removal of deep foreign bodies, muscle x2, an adjacent tissue transfer and lysis of adhesions. The hernia is noted to be a primary ventral hernia and assessed to be a class 1 (clean) wound site pre operatively. The case was performed in retro rectus fashion with component separation technique (posterior). A tar (transversus abdominis muscle release) technique was utilized. Xenmatrix ab graft was placed with a 5cm graft overlap around the hernia defect. Long-term absorbable monofilament suture was used for perimeter fixation of the graft. The midline fascia was completely closed. The skin was not fully closed and a vacuum assisted closure was performed. Drains were inserted in the right upper quadrant, left upper quadrant and in the subcutaneous space. The drains and vacuum were removed on (b)(6) 2017 and the patient was discharged from the hospital. On (b)(6) 2017 the patient was diagnosed with a seroma. Intervention has not been specified. Crf indicates the ae has been resolved with an end date of (b)(6) 2017. The ae of seroma was assessed by the health professional as being possibly related to the study device and possibly related to the procedure. The seroma was considered a grade 3 with a severity rating of serious.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1213643-2018-01106 |
| MDR Report Key | 7437250 |
| Report Source | HEALTH PROFESSIONAL,OTHER,STU |
| Date Received | 2018-04-17 |
| Date of Report | 2018-04-17 |
| Date of Event | 2017-11-24 |
| Date Mfgr Received | 2018-03-29 |
| Device Manufacturer Date | 2017-03-17 |
| Date Added to Maude | 2018-04-17 |
| 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 |
| 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 | 2018-04-17 |
| Model Number | NA |
| Catalog Number | 1153030 |
| Lot Number | HUBN1973 |
| Device Expiration Date | 2019-01-28 |
| 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 | 2018-04-17 |