MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. 3DMAX; SURGICAL MESH

Catalog Number	0115312
Medical Device Problem Codes	Defective Device (2588); Insufficient Device Problem Information (3190); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Nerve Damage (1979); Pain (1994); Hernia (2240); Disability (2371)
Date of Event	09/22/2014
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 (device 1) 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.This emdr represents the bard device implanted on (b)(6) 2014 (device 1).An additional emdr will be submitted to represent the other bard device implanted on (b)(6) 2014 (device 2).Should additional information be provided, a supplemental emdr will be submitted.Not returned.
Event or Problem Description
The patient's attorney has alleged.On (b)(6) 2014 - the patient underwent surgery for implant of two unspecified 3dmax mesh (device 1) and (device 2).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".
Event or Problem Description
The patient's attorney has alleged.(b)(6) 2014 - the patient underwent surgery for implant of two unspecified 3dmax mesh (device 1) and (device 2) 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) 2014 - patient was diagnosed with bilateral inguinal hernias thereby underwent laparoscopic repair with implant of two 3dmax meshes (device #1 & #2).Per operative notes, ¿the indirect and direct hernia sac was reduced.A 3dmax left sided (device #1) and right sided (device #2) meshes were placed into the preperitoneal space.¿ (b)(6) 2014 - patient was diagnosed with left recurrent direct inguinal hernia thereby underwent repair with the implant of bard soft mesh (device #3).Per operative notes, ¿the ilioinguinal nerve was identified and ligated with electrocautery.Attention was turned to the floor of the canal where underlying mesh from a prior repair could be palpated.A direct defect was noted, and a bard soft mesh (device #3) was then placed and secured into the ilioinguinal ligament.¿ attorney alleged that the patient had loss of testicle, nerve damage, pain and hernia recurrence.
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 (device 1) 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: this supplemental emdr is submitted to document additional information provided.Based on the additional information received, there is no change to initial determination, no conclusions can be made.Per medical records review, about 8 months post implant of 3dmax mesh, patient was diagnosed with nerve damage and hernia recurrence thereby underwent repair.The instructions-for-use supplied with the device lists hernia recurrence as a possible complication.Note, the manufacturing date (15-aug-2013) is considered to be a best estimate.This supplemental emdr represents the 3dmax (device #1).An additional supplemental emdr was submitted to represent the 3dmax (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.

• Brand Name: 3DMAX
• 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: 7339445
• Report Number: 1213643-2018-00584
• Device Sequence Number: 1447781
• Product Code: FTL
• UDI-Device Identifier: 00801741030741
• UDI-Public: (01)00801741030741(17)180928(10)HUXH1570
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K081010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/25/2024

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: 09/28/2018
• Device Catalogue Number: 0115312
• Device Lot Number: HUXH1570
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2018
• Supplement Date Received by Manufacturer: 11/05/2024
• Initial Report FDA Received Date: 03/14/2018
• Supplement Report FDA Received Date: 11/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/15/2013
• 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: Required Intervention; Disability
• Patient Age: 44 YR
• Patient Sex: Male