MAUDE Adverse Event Report: TIDI PRODUCTS LLC 5010; URO DRAIN COLLECTION BAG

Model Number 5010

Device Problem No Apparent Adverse Event (3189)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Requests made for product return and additional information including;: lot number, event date, event location, patient/caregiver involvement, initial reporter, product use information, additional history.No product returned.Companion device evaluated, no product defects were identified.Complaint defect unable to be replicated.A complaint history was reviewed.This appears to be the first complaint of this type for this product code.

Event Description

It was reported by the customer that there was an event with the uro drain bag in that the bag splits and that there is not enough solidifier in the bag to solidify the contents.

• Brand Name: 5010
• Type of Device: URO DRAIN COLLECTION BAG
• Manufacturer (Section D): TIDI PRODUCTS LLC; 570 enterprise drive; neenah 54956
• Manufacturer (Section G): TIDI PRODUCTS LLC; 570 enterprise drive; neenah WI 54956
• Manufacturer Contact: amy sanders ; 570 enterprise drive; neenah, WI 54956 ; 9207514300
• MDR Report Key: 9242462
• MDR Text Key: 177639637
• Report Number: 2182318-2019-00002
• Device Sequence Number: 1
• Product Code: MMZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 03/13/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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