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

Catalog Number	0010103
Medical Device Problem Codes	Defective Device (2588); Patient-Device Incompatibility (2682); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Granuloma (1876); Scar Tissue (2060); Hernia (2240); Injury (2348); Bowel Perforation (2668); Drug Resistant Bacterial Infection (4553)
Date of Event	03/01/2011
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At this time no conclusions can be made.The patient's attorney alleges injuries and subsequent surgery; however, no details have been provided.No lot number has been provided; therefore a review of the manufacturing records is not possible.Should additional information be provided a supplemental emdr will be submitted.Not returned.
Event or Problem Description
Attorney alleges the patient underwent surgery for implant of an unspecified bard/davol composix kugel hernia patch on (b)(6) 2007.It is alleged that the patient had subsequent surgical intervention due to the hernia mesh device(s).As reported, the patient is making a claim for an adverse patient outcome against the bard/davol composix kugel hernia patch.As reported, the attorney alleges patient experienced emotional distress and the device was defective.
Event or Problem Description
Attorney alleges the patient underwent surgery for implant of an unspecified bard/davol composix kugel hernia patch on (b)(6) 2007.It is alleged that the patient had subsequent surgical intervention due to the hernia mesh device(s).As reported, the patient is making a claim for an adverse patient outcome against the bard/davol composix kugel hernia patch.As reported, the attorney alleges patient experienced emotional distress and the device was defective.Addendum per additional information provided: (b)(6) 2007 - patient had incisional hernia thereby underwent repair with the implant of kugel patch.(note: there is no op notes were provided for this procedure in medical records) (b)(6) 2011 - patient was diagnosed with multiple recurrent incisional hernia, chronically infected mesh thereby underwent open repair with the removal of kugel patch.Per operative notes, ¿the abdominal scar and sinus tract were excised.A incisional hernia in the upper midline to the left of previously placed kugel patch.There were two perforations and a large calcified subcutaneous nodules which were likely regions of previous suture granulomas.A infected previously placed kugel patch was removed.A piece of synthetic mesh was placed and sutured.¿.
Additional Manufacturer Narrative
At this time no conclusions can be made.The patient's attorney alleges injuries and subsequent surgery; however, no details have been provided.No lot number has been provided; therefore, a review of the manufacturing records is not possible.Addendum: h11: this supplemental emdr is submitted to document additional information provided and to correct brand name and pma/510(k) #).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-aug-2007) is considered to be a best estimate.Updated fields: a2, a4, b2, b3, b4, b5, b6, b7, d4, d.6b (date of explant), g1, g3, g6, h2, h4, h6, h10, h11.Corrected field: d.1 (brand name), g4 (pma/510(k) #).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: 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 ; 4018258495
• MDR Report Key: 8852028
• Report Number: 1213643-2019-06539
• Device Sequence Number: 16217829
• Product Code: FTL
• UDI-Device Identifier: 00801741016356
• UDI-Public: (01)00801741016356(17)120928(10)HURH1226
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K963141
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Device Explanted Year: 2011
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2025

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: 09/28/2012
• Device Catalogue Number: 0010103
• Device Lot Number: HURH1226
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/18/2019
• Supplement Date Received by Manufacturer: 08/20/2025
• Initial Report FDA Received Date: 08/01/2019
• Supplement Report FDA Received Date: 09/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/15/2007
• 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; Life Threatening
• Patient Age: 46 YR
• Patient Sex: Female
• Patient Weight: 108 KG