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 2018-02-07 for XENMATRIX AB 1151935 manufactured by Davol Inc., Sub. C.r. Bard, Inc..
[99306652]
There is no connection that can be made at this time between the reported post-operative complications (seroma) and any problem with the bard/davol xenmatrix ab graft used to treat the patient. As reported the graft was implanted into a contaminated environment. The adverse event of seroma is classified by the study clinician as being possible related to the study device and definitely related to the procedure. The outcome is reported to be resolved, the graft remains implanted at this time. No definitive conclusion can be made at this time. Seroma formation is a known inherent risk of surgery and is listed in the adverse reaction section of the instructions-for-use, which are provided with the device, as a possible complication. Should additional information is provided, a supplemental emdr will be submitted. This emdr documents information associated to the bard/davol xenmatrix ab graft, an additional emdr was submitted to document information associated to the bard/davol flat mesh. 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
[99306653]
It was reported to davol that a patient who is part of a clinical study experienced a post operative seroma. On (b)(6) 2002- the patient underwent an umbilical hernia repair. (details not provided) on (b)(6) 2016 - the patient underwent bilateral breast reconstruction. On (b)(6) 2016 - the patient underwent partial removal of infected mesh (unknown) and hernia repair. On (b)(6) 2017- the patient underwent additional removal of infected mesh (unknown) with incisional hernia repair. During this procedure a bard/davol flat mesh was implanted to repair an incisional hernia. The hernia site wound was classified as class iii contaminated. On (b)(6) 2017 - the patient underwent abdominal wound debridment and local tissue rearranging. On (b)(6) 2017- the patient underwent implant of the xenmatrix ab graft for hernia repair. The hernia site classification is noted as a class iii contaminated. An intraperitoneal with component separation technique was performed in open fashion. The defect measured 15cm in length and 22cm in width. The xenmatrix ab graft was trimmed and a 5cm overlap was maintained around the hernia defect. This was a midline hernia located in the umbilical, infraumbilical and suprapubic areas. Long-term absorbable monofilament suture was used with 19 fixation points. The previously implanted bard/davol flat mesh was explanted during this procedure and was noted to be infected. Drains were inserted in the right lower quadrant and the left lower quadrant. The midline fascia and the skin were completely closed. On (b)(6) 2017 - the patient was discharged from the hospital. On (b)(6) 2017- subcutaneous drain placed in the right lower quadrant was removed. On (b)(6) 2017- the patient was diagnosed with a seroma. Drains were placed and sclerosed with doxycycline to treat the seroma. On (b)(6) 2017- subcutaneous drain placed in the left lower quadrant was removed. On (b)(6) 2017 - the patient is noted to have a healed incision and the seroma has resolved. This adverse event of seroma has been assessed as possibly related to the study device. Seroma is assessed as mild severity.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1213643-2018-00228 |
| MDR Report Key | 7249599 |
| Report Source | HEALTH PROFESSIONAL,OTHER,STU |
| Date Received | 2018-02-07 |
| Date of Report | 2018-04-17 |
| Date of Event | 2018-04-09 |
| Date Mfgr Received | 2018-03-28 |
| Device Manufacturer Date | 2016-01-30 |
| Date Added to Maude | 2018-02-07 |
| 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 | 2018-02-07 |
| Model Number | NA |
| Catalog Number | 1151935 |
| Lot Number | HUZL0464 |
| Device Expiration Date | 2017-12-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2018-02-07 |