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

Catalog Number	0113700
Medical Device Problem Codes	Defective Device (2588); Patient-Device Incompatibility (2682); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Adhesion(s) (1695); Pain (1994); Injury (2348); Disability (2371); Obstruction/Occlusion (2422)
Date of Event	05/05/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At this time no conclusions can be made to what extent the bard/davol flat mesh may have caused or contributed to the reported event.The cause of the patient postoperative complications cannot be determined at this time.The patient's attorney alleges injuries and revision surgery; however, no details have been provided.No lot number has been provided therefore a review of the manufacturing records is not possible at this time.Information is limited.Should additional information be provided a supplemental emdr will be submitted.Not returned.
Event or Problem Description
The following was alleged by the patient's attorney: on (b)(6) 2016: the patient underwent surgery for implant of an unspecified bard/davol bard mesh.The patient is only making a claim for an adverse patient outcome against the bard mesh.On (b)(6) 2017: the patient had unspecified injuries related to a defect in the bard mesh, and underwent revision surgery.The patient is only making a claim for an adverse patient outcome against the bard mesh.The attorney alleges general allegations for ¿past, present, and future damages, including but not limited to, mental and physical pain and suffering for severe and permanent personal injuries sustained by the patient.¿.
Additional Manufacturer Narrative
At this time no conclusions can be made to what extent the bard/davol flat mesh may have caused or contributed to the reported event.The cause of the patient postoperative complications cannot be determined at this time.The patient's attorney alleges injuries and revision surgery; however, no details have been provided.No lot number has been provided therefore a review of the manufacturing records is not possible at this time.Information is limited.Should additional information be provided a supplemental emdr will be submitted.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.Addendum: this supplemental emdr is submitted to document additional information provided.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-mar-2016) is considered to be a best estimate.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
The following was alleged by the patient's attorney: (b)(6) 2016: the patient underwent surgery for implant of an unspecified bard/davol bard mesh.The patient is only making a claim for an adverse patient outcome against the bard mesh.(b)(6) 2017: the patient had unspecified injuries related to a defect in the bard mesh and underwent revision surgery.The patient is only making a claim for an adverse patient outcome against the bard mesh.The attorney alleges general allegations for ¿past, present, and future damages, including but not limited to, mental and physical pain and suffering for severe and permanent personal injuries sustained by the patient.¿ addendum per medical records and plaintiff profile form: (b)(6) 2016 - patient was diagnosed with direct and indirect right inguinal hernia thereby underwent open repair with implant of bard mesh pre-shaped.Per op notes, ¿a large direct and indirect hernia sac was identified and hernia contents were reduced.A bard mesh pre-shaped was placed medially to the pubic tubercle, inferiorly to the pubic bone, superiorly to transversalis fascia and secured with tacker and sutures.¿ (b)(6) 2017 - patient was diagnosed with intestinal obstruction and left inguinal hernia thereby underwent open repair with partial excision of bard mesh pre-shaped.Per op notes, ¿the intestinal obstruction was noted.A bowel being kinked and appendix were stuck to the mesh in the right lower quadrant hernia site were lysed.Staples were removed and the portion of the mesh was debrided.Adhesive band was excised.The appendix was also removed.¿ (b)(6) 2017 - patient was diagnosed with complete mechanical bowel obstruction thereby underwent open repair.Per op notes, ¿extensive adhesions and laceration of the seromuscular layers of the bowel were lysed.A side-to-side anastomosis was done.¿.

• Brand Name: BARD MESH PRE-SHAPED
• 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 ; 4018258495
• MDR Report Key: 8294332
• Report Number: 1213643-2019-00589
• Device Sequence Number: 11159926
• Product Code: FTL
• UDI-Device Identifier: 00801741030697
• UDI-Public: (01)00801741030697(17)210228(10)HUAQ0621
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: PREAMENDMENT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/27/2025

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: 02/28/2021
• Device Catalogue Number: 0113700
• Device Lot Number: HUAQ0621
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/14/2019
• Supplement Date Received by Manufacturer: 12/05/2025
• Initial Report FDA Received Date: 01/31/2019
• Supplement Report FDA Received Date: 12/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/15/2016
• 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: Disability; Required Intervention
• Patient Age: 52 YR
• Patient Sex: Male