MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. BARD SOFT MESH PRE-SHAPED W/ KEYHOLE; SURGICAL MESH

Catalog Number	0117015
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pain is a known inherent risk of surgery and may present for any number of reasons.Pain is identified in the adverse reactions section of the instructions-for-use as a possible complication.A review of the manufacturing records found the lot was made to specification.Based on the information provided at this time, there is not connection that could be made between the reported condition being caused by the device that was used to treat the patient.As with any surgical procedure, it is possible that the patient sustained clinical complications following surgery.No definitive conclusions can be made at this time as to the cause of the alleged pain.Should additional information be provided, a supplemental emdr 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.Remains implanted.
Event or Problem Description
The following was reported to (b)(6) and forwarded to davol: on (b)(6) 2007 - the patient was implanted with a bard pre-shaped soft mesh during a procedure to repair bilateral inguinal hernias it is alleged that, "the mesh has caused chronic pain, bowel and bladder problems and many other health issues for the past ten years.Surgeons say it is impossible to remove it, certainly not without a high risk of considerable damage to tissue and organs.Regarding the mesh, no action has been taken.".

• Brand Name: BARD SOFT MESH PRE-SHAPED W/ KEYHOLE
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 100 crossings blvd.; warwick RI 02886
• MDR Report Key: 7246968
• Report Number: 1213643-2018-00207
• Device Sequence Number: 11068313
• Product Code: FTL
• UDI-Device Identifier: 00801741030925
• UDI-Public: (01)00801741030925
• Combination Product (Y/N): N
• PMA/510(K) Number: K052155
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Reporter Type: Manufacturer
• Report Source: consumer,foreign,other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/07/2018

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: 05/28/2012
• Device Catalogue Number: 0117015
• Device Lot Number: HURE1798
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/12/2018
• Initial Report FDA Received Date: 02/07/2018
• 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