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

Catalog Number	0118004
Medical Device Problem Codes	Defective Device (2588); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pain (1994); Hernia (2240); Disability (2371)
Date of Event	01/25/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Inconclusive, currently it is unknown to what extent the device may have caused or contributed to the reported event.If additional event and/or evaluation information is obtained, this report will be updated.\device not returned for evaluation.
Event or Problem Description
The following was reported to davol by the patient's attorney: (b)(6) 2007 - the patient underwent hernia repair with implant of a ck parastomal bard hernia patch.On (b)(6) 2018 - the patient underwent removal of the failed bard mesh.As reported the patient continues to experience complications related to bard mesh.The patient's attorney alleges the patient has been injured, sustained severe and permanent pain, suffering, anxiety, depression, disability and impairment due to the alleged defective bard mesh.
Event or Problem Description
The following was reported to davol by the patient's attorney: (b)(6) 2007 - the patient underwent hernia repair with implant of a ck parastomal bard hernia patch.(b)(6) 2018 - the patient underwent removal of the failed bard mesh.As reported the patient continues to experience complications related to bard mesh.The patient's attorney alleges the patient has been injured, sustained severe and permanent pain, suffering, anxiety, depression, disability and impairment due to the alleged defective bard mesh.
Additional Manufacturer Narrative
Inconclusive, currently it is unknown to what extent the device may have caused or contributed to the reported event.If additional event and/or evaluation information is obtained, this report will be updated.This emdr updates and corrects the following fields, lot expiration date and device manufacture date.Device not returned for evaluation.

• Brand Name: PARASTOMAL
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 100 crossings blvd.; warwick RI 02886
• MDR Report Key: 8165545
• Report Number: 1213643-2018-04764
• Device Sequence Number: 2015791
• Product Code: FTL
• UDI-Device Identifier: 00801741031137
• UDI-Public: (01)00801741031137
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K042026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2019

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: 06/28/2011
• Device Catalogue Number: 0118004
• Device Lot Number: 43FQD384
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/06/2018
• Supplement Date Received by Manufacturer: 04/29/2019
• Initial Report FDA Received Date: 12/14/2018
• Supplement Report FDA Received Date: 04/30/2019
• 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