ISOLATOR PLUS N95 SURGICAL RESPIRATOR
Received Mar 17, 2023
Report 1319130-2023-00001 · MDR key 16563966
Device
Generic name
Surgical Respirator
Manufacturer
Spsmedical Supply Corp. A Div. Of Crosstex Intl.Model number
GPRN95Catalog number
GPRN95
Lot number
2035081, 2103481
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
Unknown
- Abrasion
- Abrasion
Narrative
Additional Manufacturer Narrative
THE USER FACILITY RETURNED THE ISOLATOR PLUS N95 SURGICAL RESPIRATORS FOR EVALUATION. HOWEVER, A SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.
Description of Event or Problem
THE USER FACILITY REPORTED THAT STUDENTS OBTAINED CUTS ON THEIR NOSES WHILE WEARING ISOLATOR PLUS N95 SURGICAL RESPIRATORS. THE USER FACILITY DID NOT DISCLOSE IF MEDICAL TREATMENT WAS SOUGHT OR ADMINISTERED.
Additional Manufacturer Narrative
CROSSTEX HAS CONTACTED THE CUSTOMER REQUESTING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENTS AND THE STATUS OF THE STUDENTS. TO DATE, WE HAVE NOT RECEIVED ADDITIONAL INFORMATION. THERE HAVE BEEN NO OTHER COMPLAINTS ASSOCIATED WITH THE LOT NUMBERS SUBJECT OF THE REPORTED EVENTS. A FOLLOW-UP MDR WILL BE SUBMITTED SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE.