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

Catalog Number	1161928
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Codes	Abscess (1690); Adhesion(s) (1695)
Date of Event	06/16/2015
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-nov-2014) is considered to be a best estimate.This emdr represents the xenmatrix mesh (device #2).Additional emdr's were submitted to represent the bard flat mesh (device #1) and bard/davol ventralight st mesh (device #4).An additional supplemental emdr was submitted to represent the bard/davol ventralight st mesh (device #3).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) 2006 - patient was diagnosed with abdominal wall defect hernia thereby underwent open repair with the implant of bard flat mesh (device #1).Per operative notes, "a bard flat mesh (device #1) was placed and tacked." on (b)(6) 2007 - patient was diagnosed with vulvar abscess thereby underwent drainage of abscess on left.On (b)(6) 2007 - patient was diagnosed with post neovagina creation and stress urinary incontinence thereby underwent burch urethropexy.On (b)(6) 2015 - patient was diagnosed with fistula and ventral incisional hernia thereby underwent open repair with the implant of xenmatrix mesh (device #2) and resection of fistula and colon with long hartmann.Per operative notes, "lysis of adhesions performed.The xenmatrix mesh (device #2) was placed in an interposition fashion and sutured." on (b)(6) 2015 - patient was diagnosed with open wound thereby underwent open repair with the removal of mesh (device #2) and implant of ventralight st (device #3).Per operative notes, "the mesh (device #2) had separated and failed.The mesh was removed.Suture abscess was found on left upper quadrant.Adhesions between fascia and bowel was removed.A ventralight st mesh (device #3) was sutured circumferentially." on (b)(6) 2016 - patient was diagnosed with abdominal wall breakdown and enterocutaneous fistula thereby underwent takedown of indiana pouch, ileal conduit urinary diversion and removal of infected exposed mesh.Per operative notes, "abscess and adhesions were noted and removed.The infected mesh (device #3) was removed.A ventralight st mesh (device #4) was placed and sutured." on (b)(6) 2016 - patient underwent primary closure of abdominal wound.On (b)(6) 2017 - patient was diagnosed with suture granulomas and exposed mesh thereby underwent open repair with the removal of mesh (device #4).Per operative notes, "abscess cavity was noted and removed.Suture granuloma was removed from all quadrants.The unincorporated mesh (device #4) was removed.".

• 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: 22268467
• Report Number: 1213643-2025-00493
• Device Sequence Number: 11688425
• Product Code: FTM
• UDI-Device Identifier: 00801741031434
• UDI-Public: (01)00801741031434(17)161228(10)HUYK1416
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K140501
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/05/2025

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: 12/28/2016
• Device Catalogue Number: 1161928
• Device Lot Number: HUYK1416
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/27/2025
• Initial Report FDA Received Date: 06/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/15/2014
• 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: 69 YR
• Patient Sex: Female