• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

SOFRADIM PRODUCTION SAS MESH BALLYMONEY - IVS TUNNELLER¿ MESH, SURGICAL, POLYMERIC Back to Search Results
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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameMESH BALLYMONEY - IVS TUNNELLER¿
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
tracy landers
5920 longbow drive
boulder, CO 80301
3035816943
MDR Report Key14459270
MDR Text Key292198106
Report Number9615742-2022-00461
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeAS
Number of Events Reported1
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 Received05/20/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberUNKNOWN IVS TUNNELLER DEVICE
Device Catalogue NumberUNKNOWN IVS TUNNELLER DEVICE
Was Device Available for Evaluation? No
Date Manufacturer Received05/04/2022
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
-
-