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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TYCO HEALTHCARE UK MANF. LTD MESH BALLYMONEY - IVS TUNNELLER¿ MESH, SURGICAL, POLYMERIC

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TYCO HEALTHCARE UK MANF. LTD MESH BALLYMONEY - IVS TUNNELLER¿ MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number UNKNOWN IVS TUNNELLER DEVICE
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Patient Problems Bacterial Infection (1735); Erythema (1840); Fistula (1862); Micturition Urgency (1871); Hemorrhage/Bleeding (1888); Incontinence (1928); Unspecified Infection (1930); Pain (1994); Perforation (2001); Scar Tissue (2060); Urinary Retention (2119); Urinary Tract Infection (2120); Urinary Frequency (2275); Discomfort (2330); Prolapse (2475); Abdominal Distention (2601); Dysuria (2684); Fluid Discharge (2686); Unspecified Tissue Injury (4559); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Type  Injury  
Manufacturer Narrative
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. It was reported that after implant, the patient experienced prolapse, cystocele, urinary tract infection, urinary frequency, difficulty voiding/can¿t empty bladder completely, stress urinary incontinence, vaginal bleeding, nocturia, occasional enuresis, pain, tenderness, discomfort, urinary urgency, mesh protruding through the anterior vaginal wall, soreness, bladder infection, scar tissue, cystodistention, detrusor overactivity, wound infection, wound leakage, dysuria, fistula, escherichia coli, citrobacter koseri, enterococcus sp. , mrsa, klebsiella pneumonaie, pseudomonas aeruginosa, and redness. Post-operative patient treatment included anterior bridge repair, cystoscopy, partial removal of tape, physiotherapy, scar tissue was incised, vaginal repair, perineorrhaphy, suprapubic catheter placement, and medication.
 
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Brand NameMESH BALLYMONEY - IVS TUNNELLER¿
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
TYCO HEALTHCARE UK MANF. LTD
20 garryduff road             
ballymoney,at BT53 7AP 
UK BT53 7AP 
Manufacturer (Section G)
TYCO HEALTHCARE UK MANF. LTD
20 garryduff road             
ballymoney,at BT53 7AP 
UK BT53 7AP 
Manufacturer Contact
tracy landers
5920 longbow drive
boulder, CO 80301
3035816943
MDR Report Key14463186
MDR Text Key292400890
Report Number6000141-2022-00030
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeMC
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 05/20/2022
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
Device Lot Number0106009-05
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
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