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); Bacterial Infection (1735); Erosion (1750); Diarrhea (1811); Emotional Changes (1831); Micturition Urgency (1871); High Blood Pressure/ Hypertension (1908); Incontinence (1928); Pain (1994); Perforation (2001); Rash (2033); Urinary Tract Infection (2120); Urinary Frequency (2275); Discomfort (2330); Obstruction/Occlusion (2422); Prolapse (2475); Fluid Discharge (2686); 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 implant, the patient experienced bowel obstruction, abdominal pain, diarrhea, irritable bowel syndrome, diverticulitis, difficulties with bowel motions, urinary incontinence, cystocele, dyspareunia, erosion, extrusion, protrusion, hypertension, urinary tract infections, groin rash, pain, moderate feelings of frustration, and moderate emotional health impediment. Post-operative patient treatment included laminectomy, rhizotomy, parathyroid gland operation, hospitalization, colonoscopies, pelvic floor exercises, dietary changes, additional surgery, physiotherapy, incontinence nurse, antibiotics, oestrogen, pessaries, paracetamol, coversyl, nexium, panadol, calcium & vitamin d, dosulepin, coloxyl, antihistamine, and cortisone cream.

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: 14459537
• MDR Text Key: 292206776
• Report Number: 6000141-2022-00027
• 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: Foreign,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: 05/20/2022
• 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