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

Catalog Number	0118002
Medical Device Problem Codes	Defective Device (2588); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Abscess (1690); Fistula (1862); Obstruction/Occlusion (2422)
Date of Event	08/31/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No conclusions can be made.The patient's attorney alleges adverse patient outcome associated with the hernia mesh used to treat the patient including permanent injury, fistula, infection, abscess, small bowel obstruction, adhesions and subsequent surgical intervention for mesh removal.The instructions-for-use (ifu) supplied with the device lists fistula and adhesions as possible complications.A review of the manufacturing records was performed and found that the lot was manufactured to specification.In regards to the infection, the warnings section of the ifu states "if an infection develops, treat the infection aggressively.Consideration should be given regarding the need to remove the prosthesis.An unresolved infection may require removal of the prosthesis." should additional information be provided, a supplemental emdr will be submitted.Not returned.
Event or Problem Description
Attorney alleges that the patient underwent a parastomal hernia repair surgery and was implanted with a bard/davol ck parastomal hernia patch on (b)(6) 2017.It is alleged that further to the implantation with the product, the patient suffered the development of an enterocutaneous fistula, which sustained infection, causing abscessing.It is alleged that diagnostic imaging subsequently revealed irregular tissue thickening in the midline abdominal wall with entrapment of small bowel.The product had adhered to the patient's small bowel, resulting in volvulus, obstruction and ischemia.It is alleged that the patient was referred for reparative surgery to remove the product, which occurred on (b)(6) 2017.It is also alleged that the patient has suffered injuries, losses, and damages resulting from numerous defects in the product that create an unreasonably high risk of injury with severe permanent adverse health consequences.Attorney alleges that the patient experienced severe pain and suffering, including chronic pain.It is also alleged the patient was treated with a course of hospitalization, diagnostic imaging, revision surgery, serum testing, antibiotics, analgesics and rest.Attorney alleges that the patient will require further invasive repair surgery, physiotherapy, rehabilitation and will continue to require other forms of medical care.It is also alleged that the device was defective.

• Brand Name: BARD PARASTOMAL PATCH
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 100 crossings blvd.; warwick RI 02886
• MDR Report Key: 12510669
• Report Number: 1213643-2021-07615
• Device Sequence Number: 3288564
• Product Code: FTL
• UDI-Device Identifier: 00801741031113
• UDI-Public: (01)00801741031113
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K042026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/21/2021

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: 11/28/2019
• Device Catalogue Number: 0118002
• Device Lot Number: HUYJ1620
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/08/2021
• Initial Report FDA Received Date: 09/21/2021
• 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: Hospitalization; Required Intervention; Disability
• Patient Age: 63 YR