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

Catalog Number	0115810
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Defective Device (2588); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Hernia (2240); Injury (2348); Disability (2371)
Date of Event	01/21/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At this time no conclusions can be made.It is unknown to what extent the bard/davol modified kugel device may have caused or contributed to the events as alleged by the patient¿s attorney.Recurrence is a known inherent risk of hernia repair surgery and is identified in the adverse reaction section of the instructions-for-use as a possible complication.A review of the manufacturing records was performed and found that the lot was manufactured to specification.Based on the limited information provided at this time, no conclusions can be made.Should additional information be provided a supplemental emdr will be submitted.Not returned.
Event or Problem Description
The following was alleged by the patient's attorney: on (b)(6) 2014: the patient underwent surgery for repair of an incarcerated hernia.A kugel patch was implanted to repair the hernia defect.On (b)(6) 2016: the patient underwent an additional surgery to remove the mesh.During the procedure it was found that the mesh had separated from her abdominal wall and a ball of mesh was found in her abdominal cavity, causing the hernia to reappear.Patient was injured severely and permanently.As alleged, patient was injured severely and permanently.As alleged, patient has suffered and will continue to suffer physical pain and mental anguish.As reported, patient suffered and from chronic pain, as well as psychological stress and depression due to the alleged defective kugel patch.

• Brand Name: MODIFIED KUGEL
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 100 crossings blvd.; warwick RI 02886
• MDR Report Key: 8671779
• Report Number: 1213643-2019-04700
• Device Sequence Number: 2039491
• Product Code: FTL
• UDI-Device Identifier: 00801741030796
• UDI-Public: (01)00801741030796
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K963141
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/05/2019

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: 06/28/2017
• Device Catalogue Number: 0115810
• Device Lot Number: HUWF1212
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/16/2019
• Initial Report FDA Received Date: 06/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Disability