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

Catalog Number	0010104
Medical Device Problem Codes	Break (1069); Defective Device (2588)
Health Effect - Clinical Codes	Pain (1994); Disability (2371); Bowel Perforation (2668)
Date of Event	04/20/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Currently, it is unknown to what extent the device may have caused or contributed to the reported event.No medical records have been provided to date.Without a lot number a review of the manufacturing records could not be conducted.It is alleged that the patient experienced a break in the mesh.With no sample returned for evaluation the allegation of the break can not be confirmed and the reason for the alleged break can not be determined at this time.With the currently available information, no definitive conclusion can be drawn.If additional event and/or evaluation information is obtained, a follow up mdr will be submitted.This file represents the kugel patch implanted in the patient on (b)(6) 2007.Another file has been created to address the kugel patch implanted on (b)(6) 2006.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 to manufacturer.
Event or Problem Description
The following was reported to davol by the patient's attorney: on (b)(6) 2006 - the patient underwent a hernia repair surgical procedure.During the course, thereof, her physician implanted a bard hernia kugel patch (0010105) into her body.On (b)(6) 2007 - the patient underwent another hernia repair surgical procedure.During the course thereof, her physician implanted a bard hernia kugel patch (0010104) into her body.On (b)(6) 2015 - one or both of the kugel patches inserted in the patient's body broke and impaled a loop of her small bowel, causing severe pain and suffering.After less invasive methods failed to resolve the symptoms, a repair and removal surgery was performed.The attorney alleges the patient experienced a ring break, bowel injury, bowel perforation, pain, additional surgical procedure and explant.

• 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
• MDR Report Key: 6677906
• Report Number: 1213643-2017-00379
• Device Sequence Number: 10774734
• Product Code: FTL
• UDI-Device Identifier: 00801741016363
• UDI-Public: (01)00801741016363
• 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: 2007
• Device Explanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Attorney
• Type of Report: Initial
• Report Date (Section B): 06/29/2017

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: 0010104
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/06/2017
• Initial Report FDA Received Date: 06/29/2017
• 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: Life Threatening; Required Intervention; Disability