MAUDE Adverse Event Report: 3M COMPANY TAPE MICROPORE PAPER SURG 1" X 10 YD ; TAPE AND BANDAGE, ADHESIVE

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem No Code Available (3191)

Event Type  Injury  

Event Description

Indication - selective deficiency of immunoglobulin a [iga].Pt mom requested a wrap to send since the tape affects the skin of her child.Tylenol needed as well.No further info provided.Reported to cvs/caremark by pt/caregiver.Dose or amount: 1"x 10yd, frequency: as needed, route: topical.Dates of use: (b)(6) 2020 to current.

• Brand Name: TAPE MICROPORE PAPER SURG 1" X 10 YD
• Type of Device: TAPE AND BANDAGE, ADHESIVE
• Manufacturer (Section D): 3M COMPANY
• MDR Report Key: 9848153
• MDR Text Key: 184275832
• Report Number: MW5093823
• Device Sequence Number: 1
• Product Code: KGX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/06/2020

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 Operator: No Information
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/17/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1