MAUDE Adverse Event Report: SOFRADIM PRODUCTION UNKNOWN URETEX MESH PRODUCT

Model Number UNKNOWN URETEX

Device Problem Insufficient Information (3190)

Patient Problems Anemia (1706); Arthritis (1723); Bacterial Infection (1735); Chest Pain (1776); Ecchymosis (1818); Micturition Urgency (1871); Hematoma (1884); High Blood Pressure/ Hypertension (1908); Incontinence (1928); Inflammation (1932); Pain (1994); Thrombosis (2100); Thrombus (2101); Urinary Tract Infection (2120); Ulcer (2274); Injury (2348); Prolapse (2475); Blood Loss (2597); No Code Available (3191)

Event Type  malfunction  

Event Description

According to the reporter: the patient alleged injury.Medical history: stress urinary incontinence,.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4).

Event Description

The patient was diagnosed with stress urinary incontinence and urinary leakage.On (b)(6) 2002, the patient underwent a pubovaginal sling placement, suprapubic cystotomy and cytoscopy performed with a suprapubic and foley catheter placed.

Manufacturer Narrative

Additional information: (b)(4) - non-surgical interventions, surgical interventions, dyspareunia, urinary problems, hyperlipidemia, nocturia.If information is provided in the future, a supplemental report will be issued.

Event Description

Per additional information received, the patient has experienced pain, urinary problems, dyspareunia, infection, hypertension, left sided chest pain, hyperlipidemia, right femoral artery/right groin pseudoaneurysm/deep vein thrombosis (thrombosis), ¿finding was nonocclusive acute thrombus in her external and common iliac veins (thrombus), urinary tract infection, urinalysis was gram stain positive/culture and sensitivity revealed both klebsiella and e.Coli (bacterial infection), degenerative arthritis, abscess, granulation tissue, chronic inflammation, lumbar spondylosis/low back pain, right leg pain/radiculopathy, ¿infected area¿/right bartholin duct gland abscess (abscess) (infection), iron deficiency anemia/postoperative anemia (anemia), gastric ulcer, abdominal pain, gastrointestinal bleeding, ¿ecchymotic areas noted in the suprapubic region extending along to the left side¿ (ecchymosis), retropubic hematoma (hematoma), urinary urgency, nocturia, grade 2 rectocele (prolapse), mixed urinary incontinence, and required additional surgical and non surgical interventions.

• Brand Name: UNKNOWN URETEX MESH PRODUCT
• Type of Device: UNKNOWN URETEX
• 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 06473 ; 2034925267
• MDR Report Key: 4121223
• MDR Text Key: 4792142
• Report Number: 9615742-2014-00307
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Invalid Data
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/27/2014

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?: No
• Device Operator: Other
• Device Model Number: UNKNOWN URETEX
• Device Catalogue Number: UNKNOWN URETEX
• Device Lot Number: NOT AVAILABLE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/27/2014
• Initial Date FDA Received: 09/26/2014
• Supplement Dates Manufacturer Received: Not provided; 06/02/2017
• Supplement Dates FDA Received: 07/10/2015; 07/02/2017
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 92