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

Catalog Number	0010103
Medical Device Problem Codes	Defective Device (2588); Insufficient Device Problem Information (3190); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Adhesion(s) (1695); Pain (1994); Hernia (2240); Injury (2348); Disability (2371)
Date of Event	02/22/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
There is no connection that can be made at this time between the reported unspecified post-operative complications and any problem with the bard/davol kugel patch device used to treat the patient.The patient's attorney did not allege a specific device failure or patient adverse event, and no medical records have been provided.Based on the limited information provided at this time, no conclusions can be made.No lot number has been provided; therefore a review of the manufacturing records is not possible at this time.Should additional information be provided, a supplemental emdr will be submitted.The information provided by bard 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 bard.Not returned.
Event or Problem Description
The following was alleged by the patient's attorney: (b)(6) 2003 - the patient underwent surgery for implant of an unspecified bard/davol kugel hernia patch.As reported, the patient's attorney alleges a general claim "for past, present, and future damages, including but not limited to, mental and physical pain and suffering for severe and permanent personal injuries sustained".
Additional Manufacturer Narrative
There is no connection that can be made at this time between the reported unspecified post-operative complications and any problem with the bard/davol kugel patch device used to treat the patient.The patient's attorney did not allege a specific device failure or patient adverse event, and no medical records have been provided.Based on the limited information provided at this time, no conclusions can be made.No lot number has been provided; therefore a review of the manufacturing records is not possible at this time.Addendum: this supplemental emdr is submitted to document additional information provided.Based on the additional information provided, there is no change to the initial determination, no conclusions can be made.Per medical records review, about 14 years post implant of kugel patch, patient was diagnosed with hernia recurrence, adhesions thereby underwent repair with mesh removal.The instructions-for-use supplied with the device list hernia recurrence and adhesions as a possible complications.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.
Event or Problem Description
The following was alleged by the patient's attorney: (b)(6) 2003 - the patient underwent surgery for implant of an unspecified bard/davol kugel hernia patch.As reported, the patient's attorney alleges a general claim "for past, present, and future damages, including but not limited to, mental and physical pain and suffering for severe and permanent personal injuries sustained".Addendum per additional information provided: (b)(6) 2003 - patient was diagnosed with recurrent incisional/umbilical hernia thereby underwent open repair with the implant of kugel hernia patch (device #1).Per operative notes, ¿the hernia sac was excised and removed.A kugel hernia patch (device #1) was placed intra abdominally and secured using prolene sutures.¿ (b)(6) 2017 - patient was diagnosed with recurrent incisional hernia thereby underwent laparoscopic repair with removal of mesh (device #1) & resection of small bowel.Per operative notes, ¿there was a loop of small intestine that was adhered centrally right at the hernia recurrence where mesh was visible.The mesh (device #1) was sharply dissected from the peritoneum.The segmental small bowel resection with the piece of intestine that was involved with the mesh.A synthetic mesh was placed.¿ (b)(6) 2020 - patient was diagnosed with recurrent ventral hernia thereby underwent open repair with the implant of phasix mesh (device #2).Per operative notes, ¿the hernia sac is opened, and the contents are completely reduced.A piece of phasix mesh (device #2) was placed in the retro-rectus space.The corner of the mesh was sutured to the anterior abdominal wall.¿ attorney alleges that the patient had adhesions, bowel obstruction, bowel peroration, bowel removal, infection, mesh migration, pain, hernia recurrence and emotional injuries.

• Brand Name: KUGEL PATCH
• 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: 7403215
• Report Number: 1213643-2018-00933
• Device Sequence Number: 39200
• Product Code: FTL
• UDI-Device Identifier: 00801741016356
• UDI-Public: (01)00801741016356(10)43JMD276
• 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: 2003
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2025

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 Catalogue Number: 0010103
• Device Lot Number: 43JMD276
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/26/2018
• Supplement Date Received by Manufacturer: 02/13/2025
• Initial Report FDA Received Date: 04/06/2018
• Supplement Report FDA Received Date: 03/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Disability; Required Intervention
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Weight: 112 KG