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

Catalog Number	0112660
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Necrosis (1971)
Date of Event	02/27/2018
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-2013) is considered to be a best estimate.This emdr represents the bard flat mesh (device 2).Additional supplemental emdr and emdr were submitted to represent the sepramesh ip (device 1) and phasix flat 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: (b)(6) 2013 - patient was diagnosed with ventral hernia thereby underwent laparoscopic repair with the implant of sepramesh ip (device 1).Per operative notes, ¿an incision was made into the peritoneal cavity.Hernia sac was dissected out.A sepramesh ip (device 1) was placed into the abdominal cavity and secure it with sutures.¿ (b)(6) 2016 - patient was diagnosed with recurrent incarcerated incisional hernia, pain, adhesion thereby underwent open repair with explant of sepramesh ip (device 1) and implant of synthetic mesh.Per operative notes, ¿an incision was made into the right lower abdomen.Hernia sac was dissected out.There was dense adhesion into the abdomen, which was removed entirely.Previously placed sepramesh ip (device 1) was crumpled and that was removed entirely.A synthetic mesh was placed into the defect and sutured.¿ (b)(6) 2017 - patient was diagnosed with recurrent incarcerated ventral hernia, adhesion, thereby underwent open repair with implant of bard flat mesh (device 2) and phasix flat mesh (device 3).Per operative notes, ¿a lower abdomen ventral hernia sac was identified.Hernia sac was excised from abdomen.Lysis of adhesion was performed.Bard flat mesh (device 2) and phasix flat mesh (device 3) was placed into the abdominal wall and secure it with sutures.¿ (b)(6) 2018 - patient was diagnosed with abdominal wound dehiscence, necrosis thereby underwent repair with excisional debridement of lower abdominal wound.Per operative notes, ¿wound dehiscence was developed which was treated with revision and closer.All the necrotic tissue, including large amount of necrotic nonhealing fat were excised.¿.

• Brand Name: BARD FLAT MESH
• Common Device Name: 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: 23664440
• Report Number: 1213643-2025-01146
• Device Sequence Number: 10260324
• Product Code: FTL
• UDI-Device Identifier: 00801741016516
• UDI-Public: (01)00801741016516(17)181128(10)HUXK0366
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K251557
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/24/2025

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: 11/28/2018
• Device Catalogue Number: 0112660
• Device Lot Number: HUXK0366
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/03/2025
• Initial Report FDA Received Date: 11/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/15/2013
• 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: Other; Required Intervention
• Patient Age: 46 YR
• Patient Sex: Female
• Patient Weight: 102 KG