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U.S. Department of Health and Human Services

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

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SOFRADIM PRODUCTION SAS MESH SOFRADIM - UGYTEX¿ MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number UGYKA
Device Problems Device Appears to Trigger Rejection (1524); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Wound Dehiscence (1154); Erosion (1750); Cellulitis (1768); Fatigue (1849); Micturition Urgency (1871); Incontinence (1928); Pain (1994); Urinary Retention (2119); Urinary Tract Infection (2120); Urinary Frequency (2275); Injury (2348); Sleep Dysfunction (2517); Dysuria (2684); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative

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 resulting in an unspecified adverse outcome. Product was used for therapeutic treatment. The mesh was implanted for treating symptomatic cystocele and rectocele and obesity. The procedures performed were exploratory laparotomy, right salpingo-oophorectomy, lysis of adhesions, panniculectomy. Complications post avaulta placement are in 2007: patient had approximated using 1% xylocaine and closing it with prolene mattress stitch, one in the middle and one on the right side. Assessment ¿ wound separation with cellulitis and then patient had a mesh revision surgery and the complication experienced were in 2009 patient had acute urinary retention, probably temporary, urge incontinence, nocturia, mixed incontinence, stress incontinence, vaginal avaulta mesh extrusion, persistent pain with mesh and patient scheduled for removal of avaulta mesh. Complications post third mesh revision surgery in 2009 ¿ 2011 patient experienced dysuria, frequent urinary tract infection, chronic pelvic pain, vaginal atrophy, urgency now controlled by medication, chronic uti, vaginal pain with mesh, decreased libido. In 2012 she had moderate amount of pain during and after intercourse. She still has a lot of urgency and frequency. She continues to have chronic uti's, frequent urination and unable to work. She has low back pain and full bladder feeling. In 2013 patient had dyspareunia, chronic pelvic pain, bladder dysfunction, fatigue. (further gynecological records are not available to know the progress of the patient).

 
Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

 
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Brand NameMESH SOFRADIM - UGYTEX¿
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 Key7740366
MDR Text Key115728121
Report Number9615742-2018-01775
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK050187
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/03/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/01/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date09/30/2011
Device MODEL NumberUGYKA
Device Catalogue NumberUGYKA
Device LOT NumberZGJ00364
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 Received08/08/2018
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured10/01/2006
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: 08/01/2018 Patient Sequence Number: 1
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