MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 KUGEL PATCH; SURGICAL MESH

Catalog Number	0010101
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Adhesion(s) (1695); Hernia (2240)
Date of Event	01/18/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided: (b)(6) 2015: patient was diagnosed with epigastric hernia & reducible left inguinal hernia thereby underwent open repair with the implant of ventralex mesh (device #1) for epigastric hernia & implant of kugel hernia patch (device #2) for left inguinal hernia.Per op notes, ¿an incision was made in the epigastric hernia, ventralex mesh (device #1) was placed in the perifascial space using prolene sutures.An incision was made in the left lower inguinal area, a kugel hernia patch (device #2) was placed into the preperitoneal space using sutures.¿ (b)(6) 2016: patient was diagnosed with right reducible right inguinal hernia thereby underwent open repair with the implant of kugel hernia patch (device #3).Per op notes, ¿on right side, a kugel hernia patch (device #3) was placed into the preperitoneal space and was sutured to cooper¿s ligament.An incision was made parallel to the inguinal canal on the left side.The previous scar was entered.There is no indirect inguinal hernia.There is a fatty type of bulge in the direct inguinal space, and it was reduced.The mesh (device #2) is noted to be right under this.The distal lateral portion of the mesh is firmly adhered to the fascia underneath, but the medial aspect has a fatty hernia coming through it.Then, a fat was reduced, and a synthetic mesh was placed.¿.
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-mar-2014) is considered to be a best estimate.This emdr was submitted to represent the bard/davol kugel patch (device #2).An additional supplemental emdr was submitted to represent the bard/davol kugel patch (device #3).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: 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 ; 8005566756
• MDR Report Key: 22370504
• Report Number: 1213643-2025-00542
• Device Sequence Number: 14562126
• Product Code: FTL
• UDI-Device Identifier: 00801741016332
• UDI-Public: (01)00801741016332(17)190328(10)HUYC0507
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K963141
• 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): 06/26/2025

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: 03/28/2019
• Device Catalogue Number: 0010101
• Device Lot Number: HUYC0507
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/10/2025
• Initial Report FDA Received Date: 07/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/15/2014
• 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: 47 YR
• Patient Sex: Male