MAUDE Adverse Event Report: SOFRADIM PRODUCTION SAS MESH BALLYMONEY - IVS TUNNELLER¿ MESH, SURGICAL, POLYMERIC

Model Number UNKNOWN IVS TUNNELLER DEVICE

Device Problems Mechanics Altered (2984); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Adhesion(s) (1695); Bacterial Infection (1735); Diarrhea (1811); Emotional Changes (1831); Erythema (1840); Fever (1858); Fistula (1862); Micturition Urgency (1871); Hemorrhage/Bleeding (1888); Low Blood Pressure/ Hypotension (1914); Incontinence (1928); Unspecified Infection (1930); Pain (1994); Perforation (2001); Scar Tissue (2060); Urinary Retention (2119); Urinary Tract Infection (2120); Hernia (2240); Urinary Frequency (2275); Discomfort (2330); Impaired Healing (2378); Prolapse (2475); Abdominal Distention (2601); Weight Changes (2607); Dysuria (2684); Fluid Discharge (2686); Constipation (3274); Sexual Dysfunction (4510); Nodule (4551); Unspecified Tissue Injury (4559); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Event Description

The patient¿s attorney alleged a deficiency against the device. The product was used for therapeutic treatment of urinary incontinence. It was reported that after implant, the patient experienced incontinence, infections, lumps in groin, bowel trouble, diarrhea, diverticulitis, pain, constipation, anal pain, vaginal infections, bladder infections, discharge, fevers, swelling, urinary incontinence, mesh did not work, urinary retention, pelvic trauma, pelvic tumor or fibroids, unable to have sexual intercourse, adhesions, obesity, wound healing problems, naval hernias, hypotension, psychiatric injury, feelings of frustration, prolapse, cystocele, urinary tract infection, urinary frequency, difficulty voiding/can¿t empty bladder completely, vaginal bleeding, nocturia, occasional enuresis, tenderness, discomfort, urinary urgency, mesh protruding through the anterior vaginal wall, soreness, scar tissue, cystodistention, detrusor overactivity, wound infection, wound leakage, dysuria, fistula, escherichia coli, citrobacter koseri, enterococcus sp. , (b)(6), klebsiella pneumoniae, pseudomonas aeruginosa, redness, and disability. Post-operative patient treatment included removal of strings from vagina, large operation, multiple surgeries, medication, asthma meds ventolin preventers, anterior bridge repair, cystoscopy, physiotherapy, scar tissue was incised, vaginal repair, perineorrhaphy, suprapubic catheter placement, intravaginal slingopl asty, vaginal repair with additional ivs implant, and paracetamol. Surgeon was unable to remove mesh.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: MESH BALLYMONEY - IVS TUNNELLER¿
• 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: tracy landers ; 5920 longbow drive; boulder, CO 80301 ; 3035816943
• MDR Report Key: 14459270
• MDR Text Key: 292198106
• Report Number: 9615742-2022-00461
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: UNKNOWN IVS TUNNELLER DEVICE
• Device Catalogue Number: UNKNOWN IVS TUNNELLER DEVICE
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/04/2022
• 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: 05/20/2022 Patient Sequence Number: 1