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

Catalog Number	0010103
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Adhesion(s) (1695); Obstruction/Occlusion (2422); No Information (3190)
Date of Event	02/25/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As reported, the patient had symptoms similar to his crohn's disease symptoms post implant of kugel patch.Based on the information provided, no conclusion can be made as to the degree to which the bard device, may be causing or contributing the patients reported symptoms.A review of the manufacturing records was performed and found that the lot was manufactured to specification.To date this is the only reported complaint for this manufacturing lot of (b)(4) units released for distribution in april, 2012.Note, the date of implant is estimated as (b)(6) 2012 based on the information received as a specific implant date was not provided; the date of event is provided as a best estimate based on the date of awareness of the reported event.Should additional information be provided a supplemental mdr will be submitted.
Event or Problem Description
As reported, the patient was implanted with a bard kugel mesh in 2012 and has been having some symptoms similar to the patient's crohn's disease symptoms.As reported, the patient went to the doctor who did not find anything on the x-ray.
Additional Manufacturer Narrative
As reported, the patient had symptoms similar to his crohn's disease symptoms post implant of kugel patch.Based on the information provided, no conclusion can be made as to the degree to which the bard device, may be causing or contributing the patient¿s reported symptoms.A review of the manufacturing records was performed and found that the lot was manufactured to specification.To date this is the only reported complaint for this manufacturing lot of 212 units released for distribution in april, 2012.Addendum: h.11: this is an addendum to the initial mdr submitted.This supplemental mdr is submitted to report the implant date and additional surgery details received.As reported, post-implant of bard/davol kugel patch, the patient experienced bowel obstruction, adhesion and underwent subsequent surgical intervention.Adhesion is a known inherent risk of surgery and is listed in the adverse reactions section of the instructions-for-use (ifu) supplied with the device, as a possible complication.Based on the information provided, no conclusion can be made.Should additional information be provided, a supplemental mdr will be submitted.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 - remains implanted.
Event or Problem Description
As reported, the patient was implanted with a bard kugel mesh in 2012 and has been having some symptoms similar to the patient's crohn's disease symptoms.As reported, the patient went to the doctor who did not find anything on the x-ray.Addendum: as reported, during an umbilical hernia repair procedure on (b)(6) 2012, the patient was implanted with a bard/davol kugel patch which was placed extraperitoneally.As reported, about several years post-op, the patient experienced an increase in frequency of gastrointestinal issues and reported them to progressively worsen over the years and was diagnosed with a hypermobility syndrome.It was reported that on (b)(6) 2021, the patient underwent a cholecystectomy followed by removal of 5 small gall stones.As reported, the patient was diagnosed with a small bowel obstruction and underwent lysis of adhesions that were noted to be attached to the kugel patch.As reported, the patient's bowel was kinked due to the adhesion which caused the obstruction.As reported, the mesh was not removed during the procedure; however, since the kugel patch was exposed within the abdominal cavity, the surgeon opted to cover it using omental fat overlying the peritoneum.As reported, the patient has been discussing with surgeon regarding removal of the kugel patch since the abdominal issues have not resolved.

• 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: 11085363
• Report Number: 1213643-2020-20087
• Device Sequence Number: 2694837
• Product Code: FTL
• UDI-Device Identifier: 00801741016356
• UDI-Public: (01)00801741016356
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K963141
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/29/2021

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: 04/28/2017
• Device Catalogue Number: 0010103
• Device Lot Number: HUWD0417
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/11/2020
• Supplement Date Received by Manufacturer: 10/28/2021
• Initial Report FDA Received Date: 12/28/2020
• Supplement Report FDA Received Date: 11/10/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/24/2012
• 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: 78 YR
• Patient Sex: Male