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

Catalog Number	0117320
Medical Device Problem Codes	Defective Device (2588); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Hernia (2240)
Date of Event	01/15/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided by patient's attorney: (b)(6) 2013 - patient was diagnosed with right inguinal hernia and inguinodynia thereby underwent open repair with the implant of perfix plug onlay patch (device #1).Per operative notes, "a long large tubular portion of lipoma of a cord trapped in tissue was dissected.The scars were lysed.The perfix plug onlay patch was only used and secured apically to the lacunar ligament and sutured." (note: the plug portion of perfix plug was not implanted during the procedure).(b)(6) 2015 - patient was diagnosed with recurrent right inguinal hernia and right groin pain thereby underwent open repair with the explant of perfix plug onlay patch (device #1) and implant of 3dmax light mesh (device #2).Per operative notes, "the external oblique fascia was adherent to the previously placed mesh and was dissected off.The mesh was dissected from the inguinal floor.The small fat containing hernia was closed with suture and the inguinal floor was repaired.A 3dmax light mesh (device #2) was placed in the inguinal floor and tacked." (b)(6) 2016 - patient was diagnosed with bilateral direct inguinal hernia thereby underwent robotic assisted laparoscopic hernia repair with implant of two bard flat mesh (device #3 & #4).Per operative notes, "a small recurrent right direct hernia was noted.Similar findings noted on left side.Two bard flat mesh (device #3 & #4) was split, trimmed at corners and sutured." (note: there was no mention/visualization of the previously placed 3dmax light mesh (device #2) during this procedure).Attorney alleged that the patient had nerve damage, pain, hernia recurrence, loss of testicles, mesh excision surgery and emotional injuries.
Additional Manufacturer Narrative
Based on the information provided, no conclusions can be made.Per medical records review, about 8 months post implant of 3dmax light, patient was diagnosed with hernia recurrence thereby underwent revision surgery.The instructions-for-use supplied with the device list hernia recurrence as a possible complication.A review of the manufacturing records was performed and found that the lot was manufactured to specification.Note, the manufacturing date (15-dec-2014) is considered to be a best estimate.This emdr represents the 3dmax light (device #2).An additional supplemental emdr was submitted to represent the perfix plug (onlay patch - device #1).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.H3 other text: not returned.

• Brand Name: 3DMAX LIGHT
• 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: 21064579
• Report Number: 1213643-2024-094867
• Device Sequence Number: 3279111
• Product Code: FTL
• UDI-Device Identifier: 00801741031052
• UDI-Public: (01)00801741031052(17)191128(10)HUYL0164
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K091659
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/03/2025

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: 11/28/2019
• Device Catalogue Number: 0117320
• Device Lot Number: HUYL0164
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/11/2024
• Initial Report FDA Received Date: 01/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/15/2014
• 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: 32 YR
• Patient Sex: Male
• Patient Weight: 93 KG