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

Model Number UNKNOWN IVS TUNNELLER DEVICE

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Abdominal Pain (1685); Adhesion(s) (1695); Erosion (1750); Cyst(s) (1800); Purulent Discharge (1812); Eructate (1839); Incontinence (1928); Nausea (1970); Pain (1994); Vomiting (2144); Numbness (2415); Prolapse (2475); Abdominal Distention (2601); Fibrosis (3167); Constipation (3274); Unspecified Tissue Injury (4559); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Event Description

The patient¿s attorney alleged a deficiency against the device.The product was used for therapeutic treatment.It was reported that after the implant, the patient experienced dermal fibrosis, cystocele, prolapse, erosion, pain, cyst, adhesions, ovarian cyst, abdominal pain, nausea, vomiting, constipation, abdomen distention, difficulty passing stool, burping, incontinent of urine, vault palpitation, abdominal bloating, numbness, unable to walk, nerve compression, disc disease, and purulent discharge.Post-operative patient treatment included revision surgery, surgery for mesh erosion, posterior colpotomy and colporrhaphy with removal of part of the vaginal mesh/sutures.

Manufacturer Narrative

(b)(4).If information is provided in the future, a supplemental report will be issued.

• 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: 12846964
• MDR Text Key: 284510290
• Report Number: 6000141-2021-00004
• 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
• Report Date: 11/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN IVS TUNNELLER DEVICE
• Device Catalogue Number: UNKNOWN IVS TUNNELLER DEVICE
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/03/2021
• Initial Date FDA Received: 11/19/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Disability; Required Intervention
• Patient Sex: Female