MAUDE Adverse Event Report: BRIDGER BIOMED, INC. RECONIX; SURGICAL MESH

Model Number	0114510
Medical Device Problem Codes	Defective Device (2588); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pain (1994); Prolapse (2475)
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 device failure mode or patient injury was alleged.A manufacturing review was performed which found no anomalies during the manufacturing process of the device.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 limited medical records and the attorney's legal claim provided to davol by the patient's attorney: on (b)(6) 2004 - the patient was diagnosed with vaginal wall prolapse with rectocele and enterocele.The patient underwent an abdominal sacrocolpopexy with implant of a bard davol reconix mesh, vaginal posterior repair and enterocele repair.The attorney alleges the patient experienced "recurrence of original problem, severe lower abdominal pain and bowel problems." it is alleged the doctor treated the patient for pain and referred her to a pain specialist.

• Brand Name: RECONIX
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): BRIDGER BIOMED, INC.; 2430 north 7th avenue; bozeman MT 59715
• MDR Report Key: 7153035
• Report Number: 1213643-2017-01129
• Device Sequence Number: 16381046
• Product Code: FTL
• UDI-Device Identifier: 00801741011832
• UDI-Public: (01)00801741011832
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K003906
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2004
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Attorney
• Type of Report: Initial
• Report Date (Section B): 12/28/2017

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: 04/28/2008
• Device Model Number: 0114510
• Device Catalogue Number: 0114510
• Device Lot Number: 41DNBR28
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/04/2017
• Initial Report FDA Received Date: 12/28/2017
• 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