MAUDE Adverse Event Report: COVIDIEN PROTAK; ENDOSCOPIC TISSUE APPROXIMATION DEVICE

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

Patient Problems Pain (1994); Ambulation Difficulties (2544); Weight Changes (2607)

Event Date 11/18/2015

Event Type  Injury  

Event Description

I was implanted hernia mesh 15cm by 20cms.I've now gained 4 stone in weight.Lost my job and nearly my marriage due to the pain and lack of mobility.

• Brand Name: PROTAK
• Type of Device: ENDOSCOPIC TISSUE APPROXIMATION DEVICE
• Manufacturer (Section D): COVIDIEN
• MDR Report Key: 8436530
• MDR Text Key: 139429301
• Report Number: MW5085038
• Device Sequence Number: 6
• Product Code: OCW
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 03/18/2019
• 6 Devices were Involved in the Event: 1 2 3 4 5 6

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Disability
• Patient Age: 35 YR