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

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.

• 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: 14459560
• MDR Text Key: 292206534
• Report Number: 6000141-2022-00017
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• 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 Received: 05/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: UNKNOWN IVS TUNNELLER DEVICE
• Device Catalogue Number: UNKNOWN IVS TUNNELLER DEVICE
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/04/2022
• 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