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

Catalog Number	0112670
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	Injury (2348)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At this time no conclusions can be made.Based on the medical records received, there is no way to determine whether the bard flat mesh may have caused or contributed to any problems, the patient may have experienced post mesh implant.A review of the manufacturing records was performed and found that the lot was manufactured to specification.Should additional information be provided, a supplemental emdr will be submitted.
Event or Problem Description
Per information provided by the patient's attorney and medical records: 31-oct-2008 - a female patient with a past medical history of vaginal vault prolapse and enterocele formation was scheduled for repair, underwent bilateral salpingo-oophorectomy and implant of trelex graft (bard/davol flat mesh).This was secured to the vaginal apex by cv-0 non-bard/davol (gore-tex) sutures.Halban culdopexy procedure was then performed.The trelex graft (bard/davol flat mesh) was shortened and secured into the periosteum with the previously placed suture, in-folding the rough edges of the graft during ligation; fascia and skin closure was achieved.

• Brand Name: BARD FLAT 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: 10867383
• Report Number: 1213643-2020-10424
• Device Sequence Number: 11421844
• Product Code: FTL
• UDI-Device Identifier: 00801741016523
• UDI-Public: (01)00801741016523
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: PREAMENDMENT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/19/2020

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: 09/28/2010
• Device Catalogue Number: 0112670
• Device Lot Number: 43IPD032
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2020
• Initial Report FDA Received Date: 11/19/2020
• 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: Other
• Patient Age: 53 YR