MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 XENMATRIX AB; PORCINE SURGICAL MESH

Catalog Number	1151015
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Hematoma (1884); Seroma (2069)
Date of Event	12/07/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Root cause is inconclusive; no conclusion can be made as to the extent to which the implant may have caused or contributed to the patient's postoperative course.Note, the manufacturing date (15-apr-2015) is considered to be a best estimate.This mdr represents the xenmatrix ab mesh (device 2).An additional supplemental emdr was submitted to represent the composix e/x mesh (device 1).Note: section a through f - the information provided by bd 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 bd.
Event or Problem Description
Per information provided: on (b)(6) 2013 - patient was diagnosed with incarcerated ventral hernia x 2 thereby underwent laparoscopic repair with implant of composix e/x mesh (device 1).Per op notes, ¿two separate hernial defects both with incarcerated omentum and one with some small bowel loops were identified.The contents of the hernia was taken down.A piece of composix e/x mesh (device 1) was placed and fixed with the absorbatack.¿ on (b)(6) 2015 - patient was diagnosed with recurrent ventral hernia x 2 thereby underwent open repair with implant of xenmatrix ab mesh (device 2).Per op notes, ¿hernia defect was identified and the sac was formed at the edge of previous mesh (device 1) repair.Removed 2 staples from previous repair.Complex abdominal wall and thick preperitoneal fat layer was noted and both defects were sutured.A piece of xenmatrix ab mesh (device 2) was placed overlying both defects and secured with sutures.¿ on (b)(6) 2016 ¿ patient was diagnosed with seroma of abdominal wall thereby underwent drainage.Per op notes ¿upper level of seroma was identified and old metabolized hematoma was suctioned out.A jackson-part drain was placed in the seroma cavity and sutured to the skin.¿.

• Brand Name: XENMATRIX AB
• Common Device Name: PORCINE SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC. -1213643; 100 crossings blvd.; warwick RI 02886
• Manufacturer (Section G): BARD SHANNON LIMITED -3005636544; san geronimo industrial park; lot #1, road #3, km 79.7; humacao PR 00791
• Manufacturer Contact: andrew topoulos ; 100 crossings blvd.; warwick, RI 02886 ; 8005566756
• MDR Report Key: 23952898
• Report Number: 1213643-2026-00003
• Device Sequence Number: 7845179
• Product Code: PIJ
• UDI-Device Identifier: 00801741074226
• UDI-Public: (01)00801741074226(17)151028(10)HUZD0724
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K133223
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/02/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/28/2015
• Device Catalogue Number: 1151015
• Device Lot Number: HUZD0724
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2025
• Initial Report FDA Received Date: 01/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/15/2015
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 48 YR
• Patient Sex: Female