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U.S. Department of Health and Human Services

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

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SOFRADIM PRODUCTION SAS MESH SOFRADIM - URETEX MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number URETEXSUP
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Anemia (1706); Bruise/Contusion (1754); High Blood Pressure/ Hypertension (1908); Incontinence (1928); Unspecified Infection (1930); Laceration(s) (1946); Pain (1994); Vaginal Mucosa Damage (2124); Injury (2348); No Code Available (3191); Unspecified Tissue Injury (4559); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Type  Injury  
Manufacturer Narrative
This event was previously reported to the fda on an alternative summary report (asr approval #: (b)(4)) and is now being submitted on a 3500a form because of newly received information. (b)(4). If information is provided in the future, a supplemental report will be issued.
 
Event Description
The patient¿s attorney alleged a deficiency against the device. The product was used for therapeutic treatment of moderate dysplasia of the cervix, dyspareunia and urinary incontinence. The procedure performed was a total laparoscopic hysterectomy with bilateral salpingooophorectomy with robot assist, cystoscopy and transvaginal tape urethral suspension. It was reported that after implant, the patient experienced pain, infection, unspecified urinary problems, recurrence, dyspareunia, superficial periurethral/vaginal wall lacerations (vaginal mucosal damage), hypertension, bruising and decreased hemoglobin levels.
 
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Brand NameMESH SOFRADIM - URETEX
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, CT 80301
3035816943
MDR Report Key8669994
MDR Text Key147036495
Report Number9615742-2019-01794
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K012949
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 12/13/2021
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received06/05/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date10/31/2014
Device Model NumberURETEXSUP
Device Catalogue NumberURETEXSUP
Device Lot NumberHUWI1697
Was Device Available for Evaluation? No
Date Manufacturer Received11/24/2021
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: 06/05/2019 Patient Sequence Number: 1
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