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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SOFRADIM PRODUCTION SAS AVAULTA BIOSYNTHETIC SUPPORT SYSTEM MESH, SURGICAL, POLYMERIC

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SOFRADIM PRODUCTION SAS AVAULTA BIOSYNTHETIC SUPPORT SYSTEM MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number UNKNOWN SOFRADIM MESH
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Incontinence (1928); Pain (1994); Urinary Tract Infection (2120); Discomfort (2330); Injury (2348); Disability (2371); Numbness (2415); Prolapse (2475); Foreign Body In Patient (2687); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative

Concomitant product: unknown sofradim mesh (lot # unknown), unknown sofradim mesh (lot # unknown). (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. It was reported that after the implant, the patient experienced pain, injury, suffering, impairment, back pain, pelvic pain, vaginal vault prolapse, foreign body in vagina, enterocele, stress urinary incontinence, ongoing bladder pain, chronic severe vaginal pain, chronic bladder discomfort, frequent urinary tract infections, significant pain during sexual intercourse, numbness in leg, and disability. Post-operative patient treatment required intervention to prevent permanent impairment/damage.

 
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Brand NameAVAULTA BIOSYNTHETIC SUPPORT SYSTEM
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 Key10130282
MDR Text Key194382892
Report Number9615742-2020-01288
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
Report Date 06/08/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/08/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberUNKNOWN SOFRADIM MESH
Device Catalogue NumberUNKNOWN SOFRADIM MESH
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/21/2020
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: 06/08/2020 Patient Sequence Number: 1
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