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

Model Number IVS01

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abdominal Pain (1685); Abscess (1690); Adhesion(s) (1695); Bacterial Infection (1735); Erosion (1750); Emotional Changes (1831); Pain (1994); Perforation (2001); Scar Tissue (2060); Abnormal Vaginal Discharge (2123); Discomfort (2330); Prolapse (2475); Fibrosis (3167); Nodule (4551); 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 of enterocele and rectocele. It was reported that after implant, the patient experienced abscess, difficulties with bowel motions, pain, painful intercourse, adhesions, diverticulitis, moderate emotional health impediment, moderate impediment traveling, and recurrent prolapse. Post-operative patient treatment included surgeries for abscesses, buscopan, panamax, celebrex, premarin, keflex, and amitriptyline.

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: 14459614
• MDR Text Key: 292206179
• Report Number: 6000141-2022-00026
• 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,Followup
• Report Date: 05/25/2022

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 Expiration Date: 03/31/2006
• Device Model Number: IVS01
• Device Catalogue Number: IVS01
• Device Lot Number: 0302042-03
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/04/2022
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 03/31/2003
• 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