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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 Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abdominal Pain (1685); Anemia (1706); Purulent Discharge (1812); Fatigue (1849); Headache (1880); High Blood Pressure/ Hypertension (1908); Incontinence (1928); Itching Sensation (1943); Pain (1994); Rash (2033); Scar Tissue (2060); Scarring (2061); Urinary Retention (2119); Weakness (2145); Burning Sensation (2146); Chills (2191); Cramp(s) (2193); Dizziness (2194); Electrolyte Imbalance (2196); Hernia (2240); Urinary Frequency (2275); Anxiety (2328); Discomfort (2330); Injury (2348); Fungal Infection (2419); Sweating (2444); Hematuria (2558); Blood Loss (2597); Weight Changes (2607); Alteration In Body Temperature (2682); No Code Available (3191); Constipation (3274)
Event Type  Injury  
Manufacturer Narrative

Exemption number: (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 grade three cystocele, rectocele, enterocele, and urinary stress incontinence. It was reported that after implant, the patient experienced blood loss, abdominal pressure, cramping, itching, pain, bloody drainage, bloody urine (hematuria), incontinence, hernia, fatigue, sweating, hot flashes, hypomagnesemia/low sodium/low potassium (electrolyte imbalance), lightheadedness, kidney stone, urinary frequency, pelvic pain, weight fluctuations, back pain, headache, dizziness, rash, aching, elevated creatinine, elevated blood urea nitrogen, tenderness, abdominal pain, discomfort, leakage, loose stool, anxiety, soreness, low hematocrit/hemoglobin/red blood cells, elevated white blood cells, bacteria/yeast/white blood cells/leukocytes in urine (fungal infection), elevated temperature, constipation, scarring (scar tissue), nocturia, inability to urinate, urinary retention, anemia, weakness, burning sensation, hemorrhoids, chills, flushing, elevated blood pressure, additional surgical and nonsurgical 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 Key8282884
MDR Text Key134266756
Report Number9615742-2019-00170
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK033376
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type DISTRIBUTOR
Reporter Occupation
Type of Report Initial
Report Date 01/28/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/28/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberUGYKA
Device Catalogue NumberUGYKA
Device LOT NumberZHI00366
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/25/2019
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: 01/28/2019 Patient Sequence Number: 1
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