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

Catalog Number	0113710
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Pain (1994)
Date of Event	10/10/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported via ansm report no.(b)(4): as reported, the patient underwent inguinal hernia repair on (b)(6) 2019 with implant of bard pre-shaped mesh.Date of occurrence: (b)(6) 2019.Description of the incident: "i had surgery for an inguinal hernia in 2019 and was fitted with a braun plate." operative report: clinical background: the patient with a history of left inguinal hernia according to lichtenstein in 2012 and a penile wound in 2009, currently presenting with a right inguinal-scrotal hernia complicated by an episode of strangulation in (b)(6) 2019, for which inguinal plate repair is indicated.Diagnosis or operative findings: external oblique right inguinal hernia.Procedure or actions performed: inguinal plate repair according to lichtenstein.Under general anesthesia, in the supine position.After locoregional infiltration with 2% naropain per 1000.Right inguinal incision and opening of the external oblique aponeurosis.The cord is isolated and ligated.Presence of a large right external oblique hernia.The sac was freed up to the level of the neck, resected and closed at the neck with vicryl sutures.No associated direct hernia.A bard mesh was placed and fixed to the joint tendon and crural arch according to the lichtenstein technique.Closure of the external oblique aponeurosis with vicryl running sutures.Separate vicryl stitches on the superficial fascia and intradermal vicryl running sutures for rapid resorption.Current patient status: severe pain and various problems.
Additional Manufacturer Narrative
As reported, patient experienced severe pain and various problems post implant of pre-shaped mesh w/ keyhole.Based on the information reported, no conclusions can be made as to the degree to which the implant may have caused or contributed to the patient¿s postoperative course.Pain is listed in the adverse reactions section of the instructions-for-use supplied with the device, as a possible complication.A review of manufacturing records was performed and found that the device was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of (b)(4) units released for distribution.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: BARD MESH PRE-SHAPED W/ KEYHOLE
• 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: 24701125
• Report Number: 1213643-2026-00387
• Device Sequence Number: 10463301
• Product Code: FTL
• UDI-Device Identifier: 00801741030703
• UDI-Public: (01)00801741030703(17)240228(10)HUDP1756
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K251557
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/16/2026

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: 02/28/2024
• Device Catalogue Number: 0113710
• Device Lot Number: HUDP1756
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2026
• Initial Report FDA Received Date: 03/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/20/2019
• 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: Other
• Patient Age: 67 YR
• Patient Sex: Male