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 2018-01-29 for XENMATRIX AB 1151935 manufactured by Davol Inc., Sub. C.r. Bard, Inc..
[98517552]
There is no connection that can be made at this time between the reported post-operative complication (seroma) and any problem with the bard/davol xenmatrix ab graft used to treat the patient. The study subject has a complicated medical / surgical history that includes, diabetes, obesity, asthma, and multiple prior abdominal surgeries. The adverse event of seroma is classified by the clinician as being possible related to the study device and possible related to the procedure. No definitive conclusion can be made at this time. Seroma formation is a known inherent risk of surgery and is listed in 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. 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
[98517553]
It was reported to davol that a patient who is part of a clinical study experienced a post operative seroma. On (b)(6) 2017 - the patient underwent implant of the xenmatrix ab graft during a complex multi-part procedure including a colectomy, end ileostomy, splenic flexure mobilization, subtotal gastrectomy, and gastrocolic takedown. The procedure was performed intraperitoneal with component separation technique. A fistula is noted to have been present at the time of this procedure. The size of the hernia defect was 30cm in length and 15cm in width. As reported, it was necessary to trim the xenmatrix ab graft and there was a 5cm graft overlap maintained around the hernia defect. The hernia location was midline and involved the subxiphoid, epigastric, umbilical, infraumbilical and suprapubic space. The perimeter of the mesh was sutured with long-term absorbable monofilament with 33 fixation points. The midline fascia and skin were completely closed. A drain was inserted in the left upper quadrant, the left lower quadrant and the right lower quadrant. Hernia site wound classification noted as class iii (contaminated). The patient experienced acute blood loss anemia which was assessed as not device related and possibly procedure related. On (b)(6) 2017 - the patient was diagnosed with incisional cellulitis. This adverse event was assessed as not device related and possibly procedure related. The patient was started on antibiotics. On (b)(6) 2017 - the left upper quadrant drain removed. On (b)(6) 2017- the left lower quadrant drain removed. On (b)(6) 2017 - the right lower quadrant drain removed. On (b)(6) 2018 - the patient was admitted to the hospital with abdominal pain and diagnosed with a seroma. This adverse event was assessed as possibly device related and possibly procedure related. Ae required intervention and a drain was placed by interventional radiology. On (b)(6) 2018 - the patient was diagnosed with a linear ulceration. This adverse event was assessed as not device related and not procedure related. This emdr is submitted to report the formation of the post operative seroma as the event was assessed to be possible device related.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1213643-2018-00152 |
| MDR Report Key | 7226342 |
| Report Source | HEALTH PROFESSIONAL,OTHER,STU |
| Date Received | 2018-01-29 |
| Date of Report | 2018-01-29 |
| Date of Event | 2018-01-02 |
| Date Mfgr Received | 2018-01-05 |
| Device Manufacturer Date | 2015-12-15 |
| Date Added to Maude | 2018-01-29 |
| 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 | 2018-01-29 |
| Model Number | NA |
| Catalog Number | 1151935 |
| Lot Number | HUZJ0043 |
| Device Expiration Date | 2017-11-28 |
| 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. Required No Informationntervention | 2018-01-29 |