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

Catalog Number	1161928
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Seroma (2069)
Date of Event	12/02/2014
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-may-2013) is considered to be a best estimate.This mdr represents the xenmatrix (device #2).An additional supplemental emdr was submitted to represent the ventrio 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 additional information provided: (b)(6) 2013 ¿ patient was diagnosed with incisional ventral hernia thereby underwent laparoscopic to open repair with the implant of ventrio mesh (device #1).Per operative notes, ¿the large hernia defect was noted.A large piece of ventrio mesh (device #1) was placed and tacked circumferentially using sutures.¿ (b)(6) 2013 ¿ patient had abdominal pain and was diagnosed with small bowel obstruction thereby underwent laparoscopic repair with the lysis of adhesion.Per operative notes, ¿a dense amount of adhesion to anterior abdominal wall and mesh (device #1) were taken down.A portion of the small bowel had area of strictured was resected and anastomosed side to side fashion.¿ (b)(6) 2013 ¿ patient was diagnosed with deep surgical site infection thereby underwent debridement of wound.Per operative notes, ¿sutures were removed to reveal a large amount of purulent material.Some of necrotic subcutaneous tissue were debrided.¿ (b)(6) 2013 ¿ patient was diagnosed with abdominal wall abscess thereby underwent incision and drainage of abscess.Per operative notes, ¿the abscess pocket was identified, and large amount of purulent drainage was expressed.¿ (b)(6) 2014 ¿ patient was diagnosed with infected ventral hernia mesh thereby underwent open repair with the removal of mesh (device #1).Per operative notes, ¿superior to umbilicus, there was a draining sinus tract from infected mesh.The mesh (device #1) was transected in its entirety.There were minimal adhesions to mesh was identified.A biological mesh was placed intraabdominally and tacked to fascia using sutures.¿ (b)(6) 2014 - patient had preexisting abdominal wall wound with underlying hematoma thereby underwent drainage.(b)(6) 2014 - patient had chronic nonhealing anterior abdominal wall wound thereby underwent excisional debridement.(b)(6) 2014 ¿ patient was diagnosed with recurrent ventral hernia thereby underwent open repair with the implant of xenmatrix (device #2).Per operative notes, ¿the hernia contents were dissected out.The previous biological mesh was completely removed, and adhesions were lysed.A piece of xenmatrix (device #2) was placed within the abdomen and secured using sutures.¿.

• Brand Name: XENMATRIX
• 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: 22748983
• Report Number: 1213643-2025-00741
• Device Sequence Number: 8606838
• Product Code: FTM
• UDI-Device Identifier: 00801741031434
• UDI-Public: (01)00801741031434(17)150828(10)HUXE0887
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K140501
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/06/2025

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: 08/28/2015
• Device Catalogue Number: 1161928
• Device Lot Number: HUXE0887
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/05/2025
• Initial Report FDA Received Date: 08/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/15/2013
• 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
• Patient Weight: 83 KG