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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 IVS02
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abdominal Pain (1685); Bacterial Infection (1735); Purulent Discharge (1812); Emotional Changes (1831); Low Blood Pressure/ Hypotension (1914); Incontinence (1928); Unspecified Infection (1930); Muscle Weakness (1967); Nausea (1970); Pain (1994); Pneumonia (2011); Sepsis (2067); Septic Shock (2068); Urinary Retention (2119); Urinary Tract Infection (2120); Vomiting (2144); Burning Sensation (2146); Peritonitis (2252); Urinary Frequency (2275); Diaphoresis (2452); Confusion/ Disorientation (2553); Hematuria (2558); Ascites (2596); Dysuria (2684); Constipation (3274); Unspecified Tissue Injury (4559); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Type  Death  
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 vaginal reconstruction. It was reported that after implant, the patient experienced urinary tract infection, vulval lichen sclerosis, sepsis, difficulties with bowel motions, diverticulitis, urinary incontinence, urinary retention, peritonitis, hypotension, pain, infection, impairment of household chores/entertainment/physical activities, emotional changes, blood in urine, leukocytes, gram positive cocci resembling staphylococcus epidermis, klebsiella oxytoca, pseudomonas auruginosa, dysuria, nausea, vomiting, pyuria (burning urination), urinary frequency, gastroparesis, sweats, confusion, delirium, rapid decline in strength, lobar pneumonia, septic shock, urosepsis with thick purulent urine, right sided pneumonia, hypotension, hyperkalemia, hyponatremia, abdominal pain, ileus, edema, bilateral nephrosis, chronic liver disease, free intraperitoneal fluid, acute kidney injury, and death. Post-operative patient treatment included hospitalization, metaraminol infusion, dobutamine, noradrenaline infusions, and medication. Information received indicates the patient is now deceased, due to multi-organ failure from urinary system and respiratory sepsis, chronic myeloproliferative disorder and diabetes.
 
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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 Key14403548
MDR Text Key291700867
Report Number6000141-2022-00005
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 06/01/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/14/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/31/2007
Device Model NumberIVS02
Device Catalogue NumberIVS02
Device Lot Number04H109
Was Device Available for Evaluation? No
Date Manufacturer Received05/04/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured08/31/2004
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: 05/14/2022 Patient Sequence Number: 1
Treatment
GYNECARE GYNEMESH PS
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