PROCARE
Received Mar 8, 2018 · Event occurred Feb 23, 2018
Report 9616086-2018-00003 · MDR key 7324268
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Irritation
- Irritation
Narrative
Description of Event or Problem
COMPLAINT RECEIVED THAT ALLEGES PATIENT FEELS THAT SHE WAS NOT GIVEN PROPER INSTRUCTION ON THE CARE AT THE CLINIC WHERE IT WAS APPLIED, SHE WAS TOLD NOT TO REMOVE IT DUE TO THE SEVERITY OF A HUMERAL BRACE, SHE DID NOT REALIZE THAT SHE NEEDED TO REMOVE THE BRACE AND CLEAN THE ARM AND REPLACE THE SLEEVE, BECAUSE SHE DIDN'T REALIZE THIS THE SLEEVE GOT VERY MOLDY, AND CAUSED SEVERE SKIN ISSUES, THIS WAS NOTICED ON (B)(6) 2018 WHEN SHE HAD TAKEN HER SON TO THE EMERGENCY THEY HAD INSTRUCTED HER IN THE WAIT AREA TO REMOVE THE MOLDY SLEEVE IMMEDIATELY, AND THEY DISPOSED OF IT, MEANWHILE SHORTLY AFTERWARDS IN THE EMERGENCY ROOM WHEN THE DR WANTED TO EXAMINE THE AREA THEY CUT OFF THE OTHER SLEEVE AND DISPOSED OF IT AS WELL. QUESTIONNAIRE NOT RECEIVED FROM CUSTOMER OR CLINICIAN. DEVICE NOT RECEIVED MANUFACTURER AT THIS TIME.