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

Catalog Number	0117840
Medical Device Problem Codes	Defective Device (2588); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pain (1994); Disability (2371)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Currently, it is unknown whether the device may have caused or contributed to the reported event as no specific failure mode was alleged.To date no medical records have been provided.A manufacturing review was performed which found no anomalies during the manufacturing process of the device.With the current information available, no definitive conclusion can be made as to the extent that the device may have caused or contributed to any post op complications.If additional event and/or evaluation information is obtained, a follow up mdr will be submitted.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) 2005 - the patient underwent an unspecified procedure with implant of a bard/davol "marlex ptfe mesh" in her pelvic area.The attorney alleges the patient experienced pain, pain and suffering, disability, impairment and inability to engage in necessary activities.

• Brand Name: PTFE MESH
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 100 crossings blvd.; warwick RI 02886
• MDR Report Key: 6667893
• Report Number: 1213643-2017-00368
• Device Sequence Number: 1882159
• Product Code: FTL
• UDI-Device Identifier: 00801741031083
• UDI-Public: (01)00801741031083(17)100128(10)43APD175
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: PREAMENDMENT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2005
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Attorney
• Type of Report: Initial
• Report Date (Section B): 06/26/2017

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 Expiration Date: 01/28/2010
• Device Catalogue Number: 0117840
• Device Lot Number: 43APD175
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/31/2017
• Initial Report FDA Received Date: 06/26/2017
• 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: Disability