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

Catalog Number	0112700
Medical Device Problem Codes	Defective Device (2588); Insufficient Device Problem Information (3190); Patient Device Interaction Problem (4001); Migration (4003)
Health Effect - Clinical Codes	Nerve Damage (1979); Pain (1994); Scar Tissue (2060); Disability (2371)
Date of Event	04/03/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
There is no connection that can be made at this time between the reported unspecified post-operative complications and any problem with the bard/davol device used to treat the patient.The patient's attorney did not allege a specific device failure or patient adverse event, and no medical records have been provided.Based on the limited information provided at this time, no conclusions can be made.No lot number has been provided; therefore a review of the manufacturing records is not possible at this time.Should additional information be provided, a supplemental emdr will be submitted.The information provided by bard 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 bard.Not returned.
Event or Problem Description
The following was alleged by the patient's attorney: (b)(6) 2012 - the patient underwent surgery for implant of an unspecified bard/davol flat mesh.As reported, the patient's attorney alleges a general claim "for past, present, and future damages, including but not limited to, mental and physical pain and suffering for severe and permanent personal injuries sustained".
Additional Manufacturer Narrative
There is no connection that can be made at this time between the reported unspecified post-operative complications and any problem with the bard/davol device used to treat the patient.The patient's attorney did not allege a specific device failure or patient adverse event, and no medical records have been provided.Based on the limited information provided at this time, no conclusions can be made.No lot number has been provided; therefore a review of the manufacturing records is not possible at this time.Addendum: h11: this supplemental emdr is submitted to document additional information provided and to correct brand name.Based on the additional information received, there is no change to initial determination, no conclusions can be made.Per medical records review, about 2 years 9 months post implant of pre-shaped mesh, patient was diagnosed with nerve damage, pain and scar tissue thereby underwent repair with removal of mesh.Note, the manufacturing date (15-mar-2012) 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) 2012 - the patient underwent surgery for implant of an unspecified bard/davol flat mesh.As reported, the patient's attorney alleges a general claim "for past, present, and future damages, including but not limited to, mental and physical pain and suffering for severe and permanent personal injuries sustained".Addendum per additional information provided: (b)(6) 2012 - patient was diagnosed with direct left inguinal hernia thereby underwent open repair with the implant of pre- shaped mesh.Per operative notes, ¿a moderate-sized direct inguinal hernia was noted.The floor of the inguinal canal and deep ring were reconstructed using pre-shaped mesh.The mesh was secured inferiorly to the shelving edge of the inguinal ligament using sutures and the mesh was secured superiorly to the transversalis fascia using sutures.Laterally, the mesh was bifurcated and secured to itself using sutures.In such fashion, the hernia was repaired.¿ (b)(6) 2015 - patient was diagnosed with left groin pain, nerve entrapment thereby underwent open repair with the removal of mesh.Per operative notes, ¿there was dense scar tissue became apparent that the mesh and the cord had retracted inferiorly.The mesh had migrated up against the inguinal ligament.The external ring and the spermatic cord were found and dissected back through all dense scar tissue separating the cord from the mesh.Every linear white structure that could represent a sensory nerves including some through the external oblique were clamped and each end tied with sutures.The mesh was found and removed in its entirety.There was exuberant scar tissue and medial aspect of inguinal floor, the musculature had been weakened and separated from the inguinal ligament was closed with suture.¿ attorney alleged that the patient had mesh migration, pain and emotional injuries.

• Brand Name: BARD MESH PRE-SHAPED
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 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: 7352568
• Report Number: 1213643-2018-00673
• Device Sequence Number: 10901355
• Product Code: FTL
• UDI-Device Identifier: 00801741016547
• UDI-Public: (01)00801741016547(17)170328(10)HUWC1312
• 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: 2012
• Device Explanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/02/2024

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: 03/28/2017
• Device Catalogue Number: 0112700
• Device Lot Number: HUWC1312
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2018
• Supplement Date Received by Manufacturer: 11/14/2024
• Initial Report FDA Received Date: 03/20/2018
• Supplement Report FDA Received Date: 12/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/15/2012
• 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: Disability; Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male