DRIGARD TOWELS
Received Mar 26, 2019 · Event occurred Feb 26, 2019
Report 2433773-2019-00001 · MDR key 8453817
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Rash
- Local Reaction
- Rash
- Local Reaction
Narrative
Additional Manufacturer Narrative
CROSSTEX RECEIVED A REPORT THROUGH DISTRIBUTOR, (B)(4). THE REPORT STATED A FACILITY REPORTED THAT WHILE USING A CROSSTEX DRIGARD TOWEL, THE PATIENT EXPERIENCED AN ALLERGIC REACTION. CROSSTEX FOLLOWED UP WITH THE FACILITY FOR MORE INFORMATION. IT WAS REPORTED THE PATIENT EXPERIENCED SYMPTOMS OF ITCHINESS AND REDNESS ON HER SKIN AT THE CONTACT SITE FOR SEVERAL DAYS. THE USER DID SEEK MEDICAL ATTENTION AND RECEIVED STEROID SHOTS. IT WAS REPORTED THE USER'S CURRENT CONDITION IS FINE. CROSSTEX HAS NOT RECEIVED ANY SIMILAR COMPLAINTS RELATED TO THE DRIGARD TOWEL. THIS COMPLAINT WILL CONTINUE TO BE MONITORED IN THE CROSSTEX COMPLAINT HANDLING SYSTEM.
Description of Event or Problem
THE FACILITY REPORTED THAT WHILE USING A CROSSTEX DRIGARD TOWEL, THE PATIENT EXPERIENCED AN ALLERGIC REACTION.