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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SOFRADIM PRODUCTION UNKNOWN URETEX MESH PRODUCT; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR
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SOFRADIM PRODUCTION UNKNOWN URETEX MESH PRODUCT; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR Back to Search Results
Model Number UNKNOWN URETEX
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Injury (2348)
Event Date 07/19/2005
Event Type  Injury  
Manufacturer Narrative
(b)(4).(b)(6).(b)(4).
 
Event Description
Name of procedure: vaginal hysterectomy, posterior repair sling.The patient's attorney alleged a deficiency against the device resulting in an unspecified adverse outcome.Product was used for therapeutic treatment.
 
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Brand Name
UNKNOWN URETEX MESH PRODUCT
Type of Device
MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR
Manufacturer (Section D)
SOFRADIM PRODUCTION
116 avenue du formans
trevoux
FR 
Manufacturer (Section G)
SOFRADIM PRODUCTION
116 avenue du formans
trevoux
FR  
Manufacturer Contact
sharon murphy
60 middletown ave
north haven 
MDR Report Key6124536
MDR Text Key60787710
Report Number9615742-2016-00171
Device Sequence Number1
Product Code OTN
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Reporter Occupation Other Caregivers
Type of Report Initial
Report Date 10/26/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/23/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberUNKNOWN URETEX
Device Catalogue NumberUNKNOWN URETEX
Device Lot NumberSFE00270
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/26/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age33 YR
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