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

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.

• Brand Name: MESH SOFRADIM - UGYTEX¿
• Type of Device: MESH, 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 Key: 8282884
• MDR Text Key: 134266756
• Report Number: 9615742-2019-00170
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K033376
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UGYKA
• Device Catalogue Number: UGYKA
• Device Lot Number: ZHI00366
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/25/2019
• Initial Date FDA Received: 01/28/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 47 YR