FDA Adverse Event
Other
Summary report: N
3M TRANSPORE SURGICAL TAPE
MDR report key: 2886197
·
Received December 10, 2012
Report
- Report Number
- 2110898-2012-00062
- Event Type
- Other
- Date Received
- December 10, 2012
- Date of Event
- November 6, 2012
- Report Date
- November 13, 2012
- Manufacturer
- 3M HEALTH CARE
- Product Code
- ITG
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
DEVICE NOT PROVIDED TO MANUFACTURER FOR EVALUATION. COMPLAINT TYPE IS E=BEING MONITORED AND ANALYZED.
Description of Event or Problem · 1
CUSTOMER STATED AN IV WAS SECURED WITH TRANSPORE TAPE DURING A COLONOSCOPY PROCEDURE AND ALLEGES WITHIN A SHORT TIME, BEGAN TO HAVE AN "ALLERGIC" REACTION UNDER THE TAPE WHICH INCLUDED REDNESS AND HIVES. STATES HE WAS TREATED WITH ORAL PREDNISONE AND SYMPTOMS RESOLVED. STATE HAS NO PREVIOUS HISTORY OF REACTION TO ADHESIVES AND IS SEEKING A MEDICAL OPINION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 3M TRANSPORE SURGICAL TAPE | UNCLASSIFIED - TAPE | ITG | 3M HEALTH CARE | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |