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

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.

• Brand Name: MESH BALLYMONEY - IVS TUNNELLER¿
• Type of Device: MESH, 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 Key: 14403548
• MDR Text Key: 291700867
• Report Number: 6000141-2022-00005
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• 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 Received: 05/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 08/31/2007
• Device Model Number: IVS02
• Device Catalogue Number: IVS02
• Device Lot Number: 04H109
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/04/2022
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 08/31/2004
• 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