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U.S. Department of Health and Human Services

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

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SOFRADIM PRODUCTION SAS UNKNOWN SOFRADIM MESH MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number UNKNOWN SOFRADIM
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Erosion (1750); Abnormal Vaginal Discharge (2123); Urinary Frequency (2275); Injury (2348); Prolapse (2475); Abdominal Cramps (2543); 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. Product was used for therapeutic treatment. The reason for mesh implantation: symptomatic pelvic organ prolapse and genitourinary stress incontinence. The procedure performed: total vaginal hysterectomy, vaginal and perivaginal repair with avaulta graft, vaginal tape sling with uretex graft, diagnostic cystoscopy, enterocele repair with avaulta graft, rectocele repair with avaulta graft, perineoplasty and vaginal vault suspension. Findings: symptomatic uterine prolapse, symptomatic cystocele, large enterocele, symptomatic rectocele and enlarged genital hiatus. There was significant third-degree uterine prolapse, there was a fourth-degree cystocele, third-degree enterocele and third-degree rectocele. There was also enlarged genital hiatus. Complications post avaulta and uretex implantation: (b)(6) 2006-(b)(6) 2008 patient had complications like cramps across lower abdomen, knot in vaginal area causing dyspareunia, urinary frequency, narrowed vagina, vaginal discharge, underwent an in-office granulation tissue cauterization on (b)(6) 2007, recurrence of prolapse, grade ii cystocele, rectocele, mesh erosion at the vaginal apex - planned for cystocele repair with graft and will remove the mesh and perform cystoscopy on (b)(6) 2008.
 
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Brand NameUNKNOWN SOFRADIM 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 Key7663945
MDR Text Key113228532
Report Number9615742-2018-01459
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 07/05/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/05/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberUNKNOWN SOFRADIM
Device Catalogue NumberUNKNOWN SOFRADIM
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 Received01/25/2013
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: 07/05/2018 Patient Sequence Number: 1
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