MAUDE Adverse Event Report: POSEY MISCELLANEOUS; TAPE AND BANDAGE, ADHESIVE

Model Number MISC

Device Problem Missing Information (4053)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Type  Injury  

Event Description

Customer called cs to report issues with an aquaguard item.However, customer would not provide additional details (i.E.Sku, full name, phone number, etc.) event details include a call from a woman who had a bad allergic reaction to the adhesive from one of our aqua guard products.She couldn¿t get in to see a doctor for a couple of days.Further details were requested, no additional information was provided.

Manufacturer Narrative

Upon historical review of complaint data since 2009 there was one similar event for a incident involving a skin reaction to adhesive.Despite multiple attempts for more information, no further details including the outcome of the event, nor the specific details such as part number or conditions of usage were provided.User information is also unknown.The instructions for use appear to be adequate with instructions for single use, removal, and discontinuation of use if sensitivity or irritation occurs.Complaints are trended on a monthly cadence with actions taken as appropriate.(b)(4).

• Brand Name: POSEY MISCELLANEOUS
• Type of Device: TAPE AND BANDAGE, ADHESIVE
• Manufacturer Contact: chris rahn ; tidi products llc; 570 enterprise dr; neenah, WI 54956
• MDR Report Key: 12817248
• MDR Text Key: 282411610
• Report Number: 2020362-2021-00066
• Device Sequence Number: 1
• Product Code: KGX
• 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: Other
• Type of Report: Initial
• Report Date: 10/15/2021

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?: No
• Device Model Number: MISC
• Device Catalogue Number: MISC
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/15/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1