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 2016-12-15 for XENMATRIX AB 1151928 manufactured by Davol Inc., Sub. C.r. Bard, Inc..
[62421380]
Based on the information provided, at this time no conclusion can be made as to the degree to which the xenmatrix ab graft may have caused or contributed to the post surgical seroma. Seroma formation is a known inherent risk with the use of any prosthesis, and is identified in the adverse reaction section of the ifu 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 mdr will be submitted. Remains implanted.
Patient Sequence No: 1, Text Type: N, H10
[62421381]
It was reported to davol that a patient who is part of a clinical study experienced a post surgical seroma. On (b)(6) 2016 the patient was implanted with a bard xenmatrix ab graft for the repair of a primary ventral hernia in addition an intraperitoneal repair with component separation technique was performed. Drains were inserted in the right and left lower quadrants (intraperitoneal) and in the midline. The drains were removed on (b)(6) 2016 respectively. On (b)(6) 2016 the patient underwent a follow up physical exam in which an abdominal wall seroma was found and defined to be definitely related to the procedure and possible related to the device. An additional drain was placed in the right lower quadrant on (b)(6) 2016. On (b)(6) 2016 the patient underwent physical exam and the drain was removed. During this exam it is noted that the appearance of the skin over the hernia site is well healed, not bulging and no hardness to palpation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1213643-2016-00578 |
| MDR Report Key | 6175427 |
| Report Source | HEALTH PROFESSIONAL,OTHER,STU |
| Date Received | 2016-12-15 |
| Date of Report | 2016-12-14 |
| Date of Event | 2016-08-18 |
| Date Mfgr Received | 2016-11-22 |
| Device Manufacturer Date | 2015-09-15 |
| Date Added to Maude | 2016-12-15 |
| 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 BERG |
| 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 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | XENMATRIX AB |
| Generic Name | PORCINE SURGICAL MESH |
| Product Code | PIJ |
| Date Received | 2016-12-15 |
| Model Number | NA |
| Catalog Number | 1151928 |
| Lot Number | HUZH0395 |
| Device Expiration Date | 2017-07-31 |
| 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 | 2016-12-15 |