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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SOFRADIM PRODUCTION SAS PROSUP MESH, SURGICAL, POLYMERIC

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SOFRADIM PRODUCTION SAS PROSUP MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number PACGK03
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Urinary Tract Infection (2120); Prolapse (2475); Constipation (3274)
Event Date 01/01/2015
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
According to the reporter, to date, post-operative installation of an elevate band in an open procedure in 2016, patient had recurrence of bladder prolapse, back pain, constipation. Patient became handicapped with a loss of job, difficulty walking, a slipping vertebra, multiple operations for strip erosion in the bladder and vagina in the bladder and vagina, regular urinary infections.
 
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Brand NamePROSUP
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
SOFRADIM PRODUCTION SAS
116 avenue du formans
trevoux 01600
FR 01600
Manufacturer (Section G)
SOFRADIM PRODUCTION SAS
116 avenue du formans
trevoux 01600
FR 01600
Manufacturer Contact
tracy landers
5920 longbow drive
boulder, CO 80301
3035816943
MDR Report Key12425060
MDR Text Key270067967
Report Number9615742-2021-02153
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeFR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/06/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/03/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPACGK03
Device Catalogue NumberPACGK03
Device Lot NumberPFK00004
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 Received09/20/2021
Was Device Evaluated by Manufacturer? No Answer Provided
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: 09/03/2021 Patient Sequence Number: 1
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