MAUDE Adverse Event Report: Davol Inc., Sub. C.R. Bard, Inc. -1213643 Modified Kugel Patch; Surgical Mesh

Catalog Number	0115810
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Codes	Adhesion(s) (1695); Pain (1994); Hernia (2240)
Date of Event	09/21/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided: on (b)(6) 2016 - patient was diagnosed with bilateral inguinal hernias thereby underwent open repair with implant of modified kugel patch (device 1 - right and device 2 - left).Per operative notes, "a right groin incision was made to the external oblique which was dissected to the inguinal ligament.The hernia sac was dissected out.A modified kugel patch (device 1) was placed onto the right inguinal floor and secured it with sutures.A left groin incision was made in a symmetric mirror fashion, and the exposure was identical as described on the right.The hernia sac was dissected out.A modified kugel patch (device 2) was placed into the left inguinal floor and secured it with sutures." on (b)(6) 2018 - patient was diagnosed with bilateral recurrent inguinal hernias, groin pain, adhesion thereby underwent laparoscopic repair with implant of 3dmax light mesh (device 3 - right and device 4 - left) and explant of modified kugel patch (device 1 and device 2).Per operative notes, "a right groin incision was made through old incision.The hernia sac was dissected out.There was visible mesh (device 1) protruding.The peritoneum was inadvertently entered.Previously placed modified kugel patch (device 1) was excised entirely.A 3dmax light mesh (device 3) was placed into the right groin and secured it with sutures.Another incision was made into the left groin.The hernia sac was dissected out.There was a visible mesh (device 2) protruding.As previously, encountered the modified kugel patch (device 2) that was adherent to the sutures.The modified kugel patch (device 2) was totally excised.A 3dmax light mesh (device 4) was placed into the left groin and secured it with sutures.".
Additional Manufacturer Narrative
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-feb-2016) is considered to be a best estimate.This emdr represents the modified kugel patch (device 2).An additional supplemental emdr was submitted to represent the modified kugel 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.

• Brand Name: Modified Kugel Patch
• 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 ; +1(800)556-6756
• MDR Report Key: 50433162
• Report Number: 1213643-2026-01091
• Device Sequence Number: 10397835
• Product Code: FTL
• UDI-Device Identifier: 00801741030796
• UDI-Public: (01)00801741030796(17)210228(10)HUAP0743
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K963141
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/17/2026

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: 02/28/2021
• Device Catalogue Number: 0115810
• Device Lot Number: HUAP0743
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/12/2026
• Initial Report FDA Received Date: 08/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/15/2016
• 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: Required Intervention
• Patient Sex: Male
• Patient Weight: 189 LB