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 2017-04-11 for XENMATRIX AB 1152025 manufactured by Davol Inc., Sub. C.r. Bard, Inc..
[72335351]
Based on the information provided we are unable to determine to what extent if any, the bard device may have caused or contributed to the patient post operative pain and seroma. The adverse events were assessed as possibly related to the device and definitely related to the procedure. Seroma is a known inherent risk of surgical procedures and is listed in the adverse reaction section of the ifu as a possible complication. Should additional information be reported regarding the patient's condition, a supplemental mdr 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. Device remains implanted.
Patient Sequence No: 1, Text Type: N, H10
[72335352]
The following was reported and is associated with the (b)(4). On (b)(6) 2016 - the patient was implanted with a bard xenmatrix ab graft for the treatment of a recurrent ventral incisional hernia. The 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. On (b)(6) 2016- the patient presented for her three month postop visit. A 3cm x 3cm, soft non tender seroma below the umbilicus was revealed. There was no medical / surgical intervention. The seroma was assessed as possibly related to the device and definitely related to the procedure. On (b)(6) 2016 - the patient was diagnosed with abdominal pain of moderate severity. The pain was assessed as possibly related to the device and possibly related to the procedure. There was no action taken and no intervention required. There was no mention of a seroma. On (b)(6) 2016 - the patient was seen at the six month postop visit. The patient was assessed to have a well healed midline scar. Non tender to touch. The seroma had resolved.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1213643-2017-00228 |
| MDR Report Key | 6479687 |
| Report Source | HEALTH PROFESSIONAL,OTHER,STU |
| Date Received | 2017-04-11 |
| Date of Report | 2017-04-11 |
| Date of Event | 2016-09-01 |
| Date Mfgr Received | 2017-03-14 |
| Device Manufacturer Date | 2016-01-29 |
| Date Added to Maude | 2017-04-11 |
| 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 | 2017-04-11 |
| 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. Other | 2017-04-11 |