FDA Adverse Event
Other
Summary report: N
URI DRAIN IND W/STRAP
MDR report key: 2997564
·
Received March 5, 2013
Report
- Report Number
- 9612030-2013-00005
- Event Type
- Other
- Date Received
- March 5, 2013
- Report Date
- February 12, 2013
- Manufacturer
- COVIDIEN LP, FORMERLY REGISTERED AS KENDALL KENMEX
- Product Code
- NNZ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
SUBMIT DATE: (B)(4) 2013. AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.
Description of Event or Problem · 1
IT WAS REPORTED TO COVIDIEN ON (B)(6) 2013 THAT A CUSTOMER HAD AN ISSUE WITH A URI DRAIN. THE CUSTOMER REPORTED THAT THEY HAVE USED THIS PRODUCT FOR MANY YEARS AND IS NOW HAVING A REACTION TO THEM. THE CUSTOMER REPORTS HAVING A REACTION CAUSING REDNESS, BLISTERS THAT HAVE POPPED AND IS NOW RAW RED. THE PATIENT WAS SEEN AT HIS DOCTOR¿S OFFICE AND WAS PRESCRIBED BACTROBAN CRAM AND SIPRO ANTIBIOTICS 500 MG TO BE TAKEN TWICE A DAY. HE IS REVISITING HIS DOCTOR AS NO IMPROVEMENT TO THE CONDITION HAS BEEN MADE WITH THE ANTIBIOTICS, AND THE DISCONTINUANCE OF THE DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 94199 | URI DRAIN IND W/STRAP | URI DRAIN | NNZ | COVIDIEN LP, FORMERLY REGISTERED AS KENDALL KENMEX | 8884732300 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 42 YR | Other |