MAUDE Adverse Event Report: TORBOT GROUP, INC. SKIN TAC WIPES; COLLECTOR, OSTOMY

Lot Number A127

Patient Problems Rash (2033); Blister (4537)

Event Date 12/29/2022

Event Type  Injury  

Event Description

I purchased skin tac wipes and my skin broke out in a blistering rash where the product was applied; topical, to help an omnipod device adhere to skin.Dates of use: (b)(6) 2022- (b)(6) 2022.To help an omnipod device adhere to skin.

• Brand Name: SKIN TAC WIPES
• Type of Device: COLLECTOR, OSTOMY
• Manufacturer (Section D): TORBOT GROUP, INC.
• MDR Report Key: 16113142
• MDR Text Key: 306895260
• Report Number: MW5114199
• Device Sequence Number: 1
• Product Code: EXB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 01/04/2023

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 Lot Number: A127
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/05/2023
• Patient Sequence Number: 1
• Treatment: OMNIPOD
• Patient Age: 57 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White