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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 IVS02M
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Patient Problems Adhesion(s) (1695); Erosion (1750); Emotional Changes (1831); Micturition Urgency (1871); Incontinence (1928); Muscle Weakness (1967); Pain (1994); Urinary Retention (2119); Urinary Frequency (2275); Discomfort (2330); Prolapse (2475); Ascites (2596); Fluid Discharge (2686); Fibrosis (3167); 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 of cystocele, rectocele, and prolapse. It was reported that after the implant, the patient experienced induration, prolapse, pelvic floor weakness, loculated draining collection in the posterior wall, vaginal dryness, laxity of the anterior and posterior walls, mild atrophic vaginal changes, tenderness, fibrosis, adhesions, dyspareunia, pain, atrophic vaginitis, urinary urgency/leakage, incomplete bladder emptying, post micturition dribbling, stage 2 rectocele, jagging sensations, sexual difficulties, psoriasis has been exacerbated, suffered psychologically, eroding mesh, frequency, urgency and incontinence. Post-operative patient treatment included medication, physiotherapy, and excision of ivs tape segment/suture.
 
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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
lisa hernandez
60 middletown ave.
north haven, CT 06473
2034925563
MDR Report Key11731645
MDR Text Key247487781
Report Number6000141-2021-00001
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K010035
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 04/27/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/27/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberIVS02M
Device Catalogue NumberIVS02M
Device Lot Number06E029
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/09/2021
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: 04/27/2021 Patient Sequence Number: 1
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