CAREFUSION
Received Jun 11, 2014 · Event occurred May 12, 2014
Report 1424490-2014-00001 · MDR key 3883992
Device
Generic name
Strap, Head, Gas Mask
Manufacturer
Carefusion 211, Inc.Model number
PURESOM RUBY ADJUSTABLECatalog number
TMS-09 ADJ
Lot number
011013A01
Product problems
- Use of Device Problem
- Biocompatibility
Patient
UNK
- Itching Sensation
- Rash
- Discomfort
Narrative
Description of Event or Problem
AN EMAIL WAS SENT TO SLEEP SUPPORT VIA THE CAREFUSION WEBSITE. IT READ: "I'M GUESSING THAT YOU HAVE CHANGED THE MANUFACTURING OF YOUR CHIN STRAP. I LOVED THE FIRST ONE I HAD, BUT IT GOT OLD AND SOMEWHAT FUZZY. THE NEW ONE ITCHED FROM THE FIRST DAY I WORE IT, ALMOST LIKE FIBERGLASS FIBERS IN MY CHIN. I WASHED IT SEVERAL TIMES AND IT WAS VERY SLIGHTLY BETTER. HOWEVER, NOW I HAVE A RASH FROM IT AND HAVE DISCONTINUED USING IT."
Additional Manufacturer Narrative
THE END USER/PATIENT DID NOT SUBMIT A USER FACILITY/IMPORTER REPORT TO THE MANUFACTURER. EVENT CODES WERE DERIVED BASED ON INFO PROVIDED BY THE END USER/PATIENT. (B)(4). THE PURESOM RUBY ADJUSTABLE CHINSTRAP HAS BEEN RECEIVED, ROUTED TO THE CAREFUSION FAILURE ANALYSIS LAB AND STAGED FOR EVALUATION. ONCE THE EVALUATION IS COMPLETED, A F/U MEDWATCH REPORT WILL BE SUBMITTED.