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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 Migration or Expulsion of Device (1395); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Patient Problems Abdominal Pain (1685); Adhesion(s) (1695); Erosion (1750); Calcium Deposits/Calcification (1758); Purulent Discharge (1812); Emotional Changes (1831); Fistula (1862); Micturition Urgency (1871); Hematoma (1884); Incontinence (1928); Pain (1994); Perforation (2001); Abnormal Vaginal Discharge (2123); Urinary Frequency (2275); Discomfort (2330); Obstruction/Occlusion (2422); Prolapse (2475); Constipation (3274); Nodule (4551); Unspecified Tissue Injury (4559); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Type  Injury  
Manufacturer Narrative
(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 urinary incontinence. It was reported that after implant, the patient experienced mesh migration, bowel obstruction, bowel perforation, constipation, difficulties with bowel motions, urinary incontinence, uterine prolapse, pelvic trauma, vaginal pain, painful intercourse, damage to pelvic organs, nerves, ligaments, tissue, erosion, extrusion, protrusion, adhesions, fistula, pain, impairment of activities, emotional changes, anal lesions, calcifications, hematoma, fibroadipose and muscular tissue, tenderness, vaginal discharge, dyspareunia, urinary frequency, vaginal atrophy, vaginal lump, abdominal pain, perineal discomfort, white discharge, urinary urgency, cystocele. Post-operative patient treatment included revision surgery, medication, physiotherapy, colonoscopy, ileoscopy, biopsy of peri anal lesions, hospitalization, perineum biopsy, mri, skg radiology, nerve block injection inside vagina, vaginal pessary placed.
 
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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 Key14459560
MDR Text Key292206534
Report Number6000141-2022-00017
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
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