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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 UGYKP
Device Problems Material Erosion (1214); Migration or Expulsion of Device (1395); Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abdominal Pain (1685); Anemia (1706); Bacterial Infection (1735); Erosion (1750); Dehydration (1807); Ecchymosis (1818); Micturition Urgency (1871); Headache (1880); Failure of Implant (1924); Incontinence (1928); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Staphylococcus Aureus (2058); Scar Tissue (2060); Urinary Retention (2119); Urinary Tract Infection (2120); Discomfort (2330); Injury (2348); Prolapse (2475); Hematuria (2558); Blood Loss (2597); Foreign Body In Patient (2687); Fibrosis (3167); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
This event was previously reported to the fda on an alternative summary report (asr approval #: e2013038b) and is now being submitted on a 3500a form because of newly received information. (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 pain, total pelvic relaxation, stress urinary incontinence and menorrhagia. It was reported that after implant, the patient experienced blood loss, vaginal mesh/left anterior graft erosion, dyspareunia, pain with palpation of anterior/posterior apical arms, tenderness posteriorly near the introitus at palpation of the mesh, granulation tissue, left posterior graft constriction/constriction band, urinary tract infection, (b)(6) (bacterial infection), pyelonephritis, back pain, pelvic pain, graft had grown into the surrounding tissue and became very fibrotic (fibrosis, foreign body in patient), failed graft (failure of implant), erosion, extrusion, infection, unspecified urinary problems, unspecified bowel problems, unspecified neuromuscular problems, vaginal scarring, abdominal pain, vaginal bleeding, recurrence, stress urinary incontinence, migration, mild ecchymosis on bilateral gluteal regions, anemia, dehydration, persistent headache, reflux symptoms, inability to void, foley replacement, urinary retention, neurogenic pain, buttocks pain, vaginal pain, hematuria, urgency, right leg pain, (b)(6), cystitis and pyelonephritis, back problems and tenderness, mild diffuse bladder wall thickening, graft erosion, revision of anterior graft, revision of posterior graft, (b)(6), vaginal infection, discomfort in the vaginal area, placement of peripherally inserted central catheter, dyspareunia, vaginal mesh erosion with revision of transvaginal mesh and multiple non-surgical and surgical interventions.
 
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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 Key8676480
MDR Text Key147254734
Report Number9615742-2019-01830
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K051503
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 06/06/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/06/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/31/2008
Device Model NumberUGYKP
Device Catalogue NumberUGYKP
Device Lot NumberCVR10041
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/04/2019
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: 06/06/2019 Patient Sequence Number: 1
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