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

Model Number	0117010
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Codes	Pain (1994); Prolapse (2475)
Date of Event	02/23/2011
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 explant event.Per the operative details, during the partial explant procedure it was noted that the soft mesh was identified in its proper location from the sacral prominence to the vaginal cuff/ cervical stump.During the procedure and post explant there was no specific device malfunction alleged against the mesh.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 is based on a review of medical records provided to davol by the patient's attorney: on (b)(6) 2009 - the patient was diagnosed with prolapse of vaginal vault, mixed incontinence urge and stress incontinence.The patient underwent an abdominal sacrocolpopexy with implant of a bard soft mesh and implant of a non-bard davol urethral sling followed by cystoscopy.On (b)(6) 2011 - the patient was diagnosed pelvic pain and underwent an exploratory laparotomy with partial explant of bard soft mesh.Per operative details, "attention was turned to the abdominal sacrocolpopexy mesh which was identified in its proper location from the sacral prominence to the vaginal cuff/ cervical stump." on (b)(6) 2012 - the patient was diagnosed with a vaginal enterocele and cystocele.The patient underwent a vaginal anterior/posterior repair with implant of a non-bard davol "tutoplast fascia lata."no mention of any involvement or visualization of the bard soft mesh.

• Brand Name: SOFT 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: 7112788
• Report Number: 1213643-2017-01019
• Device Sequence Number: 11045597
• Product Code: FTL
• UDI-Device Identifier: 00801741030871
• UDI-Public: (01)00801741030871
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K052155
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2011
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Attorney
• Type of Report: Initial
• Report Date (Section B): 12/13/2017

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: 02/28/2013
• Device Model Number: 0117010
• Device Catalogue Number: 0117010
• Device Lot Number: HUSB0069
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/13/2017
• Initial Report FDA Received Date: 12/13/2017
• 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: Required Intervention
• Patient Age: 46 YR
• Patient Weight: 97