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U.S. Department of Health and Human Services

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

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SOFRADIM PRODUCTION SAS UNKNOWN MESH MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number 481068
Device Problems Material Erosion (1214); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Adhesion(s) (1695); Erosion (1750); Emotional Changes (1831); Incontinence (1928); Nerve Damage (1979); Pain (1994); Scar Tissue (2060); Urinary Tract Infection (2120); Cramp(s) (2193); Anxiety (2328); Injury (2348); Depression (2361); Obstruction/Occlusion (2422); Prolapse (2475); Blood Loss (2597); Abdominal Distention (2601); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
(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 pelvic organ prolapse and prolapsed colon via bladder sling repair. It was reported that after implant, the patient experienced erosion, painful sex, chronic utis, cramping, pain, constant doctor visits, fear, embarrassment, back pain, nerve damage, incomplete urine voiding, incontinence, manipulation required for bowel movements, scar tissue, fecal bulging out of vagina, adhesions, bleeding, bowel obstruction, cystocele of fecal matter, dyspareunia, muscle wasting disorder, neuromuscular disease, obesity, recurrent vaginal pain, anxiety and depression. Post-operative patient treatment included partial removal surgery antidepressants, mood stabilizers and hormone medications.
 
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Brand NameUNKNOWN MESH
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
lisa hernandez
60 middletown ave
north haven, CT 06473
2034925563
MDR Report Key8908555
MDR Text Key154834213
Report Number9615742-2019-02859
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/21/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/19/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number481068
Device Catalogue Number481068
Device Lot Number10B07-1
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/24/2019
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: 08/19/2019 Patient Sequence Number: 1
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