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U.S. Department of Health and Human Services

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

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BRIDGER BIOMED, INC. RECONIX SURGICAL MESH Back to Search Results
Model Number 0114510
Device Problems Defective Device (2588); Insufficient Information (3190)
Patient Problems Pain (1994); Prolapse (2475)
Event Type  Injury  
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 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.
 
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Brand NameRECONIX
Type of DeviceSURGICAL MESH
Manufacturer (Section D)
BRIDGER BIOMED, INC.
2430 north 7th avenue
bozeman MT 59715
Manufacturer (Section G)
BRIDGER BIOMED, INC. -3031159
2430 north 7th avenue
bozeman MT 59715
Manufacturer Contact
steven figueroa
100 crossings blvd.
warwick, RI 02886
4018258460
MDR Report Key7153035
MDR Text Key96003819
Report Number1213643-2017-01129
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K003906
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Reporter Occupation Attorney
Type of Report Initial
Report Date 12/28/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/28/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date04/28/2008
Device Model Number0114510
Device Catalogue Number0114510
Device Lot Number41DNBR28
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/04/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/15/2003
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/28/2017 Patient Sequence Number: 1
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