NITROSPRAY PLUS
Received Dec 8, 2020 · Event occurred Dec 1, 2020
Report 2511556-2020-00001 · MDR key 10969166
Device
Generic name
Cryosurgical Unit
Manufacturer
Premier Dental Products Co.Model number
1006060Catalog number
1006060
Lot number
14623
Product problems
- Free or Unrestricted Flow
- Misassembly by Users
- Free or Unrestricted Flow
- Misassembly by Users
Patient
Not reported
- Blister
- Cryogenic Burn
- Blister
- Cryogenic Burn
Narrative
Additional Manufacturer Narrative
DURING THE INTERVIEW WITH THE OFFICE, IT WAS DISCLOSED THAT A SPRAY TIP WAS NOT APPLIED TO THE NITROSPRAY PLUS NOZZLE. THE INSTRUCTIONS FOR USE WERE NOT FOLLOWED. SUBMITTING REPORT AGAIN TO CORRECT THE ERROR OF SUMMARY REPORT BOX BEING CHECKED.
Description of Event or Problem
DUE TO USER ERROR, TWO PATIENTS HAD BLISTERING AFTER TREATMENT. PATIENTS WERE MONITORED FOR HEALING, BOTH BURNS WERE NOT SERIOUS AND DID NOT REQUIRE MEDICAL TREATMENT.
Additional Manufacturer Narrative
DURING THE INTERVIEW WITH THE OFFICE, IT WAS DISCLOSED THAT A SPRAY TIP WAS NOT APPLIED TO THE NITROSPRAY PLUS NOZZLE. THE INSTRUCTIONS FOR USE WERE NOT FOLLOWED.
Description of Event or Problem
DUE TO USER ERROR, TWO PATIENTS HAD BLISTERING AFTER TREATMENT. PATIENTS WERE MONITORED FOR HEALING, BOTH BURNS WERE NOT SERIOUS AND DID NOT REQUIRE MEDICAL TREATMENT.