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

Catalog Number	0112720
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Adhesion(s) (1695); Scar Tissue (2060); Hernia (2240)
Date of Event	05/10/2016
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-aug-2012) is considered to be a best estimate.This mdr represents the bard/davol flat mesh (device #1).An additional supplemental emdr was submitted to represent the bard/davol ventralight st (device #2).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 incarcerated incisional hernia thereby underwent open repair with implant of bard flat mesh (device 1).Per op notes, ¿previous infraumbilical vertical scar was reopened.A large hernia with small bowel hernia was identified and reduced.A bard flat mesh (device 1) was placed over the completed closure of fascia and tacked with sutures.¿ (b)(6) 2016 - patient was diagnosed with recurrent incisional hernia thereby underwent open repair with implant of ventralight st mesh (device 2).Per op notes, ¿incision was made above the umbilicus and reopened the prior incision.The overlay mesh (device 1) was intact.A ventralight st mesh (device 2) was placed as an underlay and secured with sutures.¿ (b)(6) 2019 ¿ patient was diagnosed with incisional hernia thereby underwent robotic assisted repair with excision of ventralight st (device 2) and implant of synthetic mesh.Per op notes, ¿previous sublay mesh (device 2) was identified with large amount of adhesions and scar tissue which was dissected free.A ventralight st (device 2) was excised.The onlay mesh (device 1) was left in place.A synthetic mesh was placed into the peritoneal cavity and lay flat and tension free.¿.

• 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: 24207869
• Report Number: 1213643-2026-00050
• Device Sequence Number: 18547930
• Product Code: FTL
• UDI-Device Identifier: 00801741016561
• UDI-Public: (01)00801741016561(17)170828(10)HUWH0464
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K251557
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/22/2026

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: 08/28/2017
• Device Catalogue Number: 0112720
• Device Lot Number: HUWH0464
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/08/2026
• Initial Report FDA Received Date: 01/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/15/2012
• 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: 55 YR
• Patient Sex: Female