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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SOFRADIM PRODUCTION UNKNOWN UGYTEX MESH PRODUCT MESH, SURGICAL, POLYMERIC
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SOFRADIM PRODUCTION UNKNOWN UGYTEX MESH PRODUCT MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number UNKNOWN UGYTEX
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Erosion (1750); Unspecified Infection (1930); Pain (1994); Swelling (2091); Urinary Tract Infection (2120); Discomfort (2330); Injury (2348); No Code Available (3191)
Event Date 05/18/2007
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
(b)(4).
 
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 patient underwent an a+p repair, both with a mesh graft placement and bilateral sacropinous ligament fixation and ileo-coccygeral vaginal vault suspension and enterocele repair and tot, and cystoscopy and perineoplasty. The preoperative and postoperative diagnosis was grade ii rectocele, grade ii cystocele. Vaginal vault prolapse, paravaginal defect, enterocele, poor perineal body support, stress urinary incontinence, and intrinsic sphincter deficiency. On (b)(6) 2007 the patient presented with a uti. She had some aches and pains and twinges here and there. On (b)(6) 2007 the patient said she had some discomfort at the introital area. On (b)(6) 2007 the patient presented for a follow up with some dyspareunia and vaginal pain. On (b)(6) 2009 the patient was referred to a doctor regarding dyspareunia, pain, and swelling in a prior surgical site. On (b)(6) 2009 the patient underwent a cystoscopy x2 and transvaginal excision of foreign body per vagina. The preoperative and postoperative diagnosis was foreign body erosion into vagina status post prior transobturator tape sling.
 
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Brand NameUNKNOWN UGYTEX MESH PRODUCT
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
SOFRADIM PRODUCTION
116 avenue du formans
trevoux
FR
Manufacturer (Section G)
SOFRADIM PRODUCTION
116 avenue du formans
trevoux
FR
Manufacturer Contact
sharon murphy
60 middletown ave
north haven,ct, CT 06473
2034925267
MDR Report Key6186013
MDR Text Key119385075
Report Number9615742-2016-00210
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 Non-Healthcare Professional
Type of Report Initial,Followup,Followup
Report Date 09/05/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/19/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberUNKNOWN UGYTEX
Device Catalogue NumberUNKNOWN UGYTEX
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/23/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 12/19/2016 Patient Sequence Number: 1
Treatment
MESH
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