D
Patient 1
THE PT WAS RECEIVING DIALYSIS AND GEBAUER'S ETHYL CHLORIDE MIST SPRAY (LOT 3068) WAS APPLIED FOR PRE-INJECTION ANESTHESIA. THE PT REPORTED BURNING, BLISTERING, SCABBING AND DISCOLORATION AFTER APPLICATION OF THE PRODUCT.
MAUDE MDR 4736168
- MDR report key
- 4736168
- Report number
- 1519179-2015-00001
- Event key
- 0
- Event type
- 3
- Date of event
- 2015-03-27
- Date received
- 2015-04-28
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 2
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 0
Manufacturer Contact#
- Contact
- AMY PAUKPVITS
- Address
- 4444 E. 153RD ST. CLEVELAND OH 44128 US
- Phone
- 216-216-2165
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | GEBAUER'S ETHYL CHLORIDE MIST SPRAY | CAPOCOOLANT | GEBAUER CO. | MLY | 0386-0001-02 | 3068 | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2015-04-28 | 0 | 1. H |
Event Narratives#
N
Patient 1
THE COMPLAINT AS REPORTED IDENTIFIED THAT THE PT FELT A BURNING SENSATION IMMEDIATELY AFTER THE PRODUCT WAS APPLIED THAT RESULTED IN BLISTERING, SCABBING AND DISCOLORATION. THESE ADVERSE EVENTS ARE TYPICALLY ASSOCIATED WITH FROSTBITE THAT COULD RESULT FROM OVER-APPLICATION OF THE DEVICE. THE COMPLAINANT, WHO DID NOT SPEAK TO THE PT DIRECTLY WAS TOLD THE PRODUCT WAS APPLIED BY A NURSE FOR APPROX 5 SECONDS. A 5 SECOND SPRAY IS WITHIN THE IFU BUT IF THE SKIN HAD TURNED WHITE PRIOR TO THE 5 SECONDS, THE SPRAY SHOULD HAVE BEEN STOPPED PER THE DIRECTIONS FOR USE. ALSO, ALTHOUGH RARE, THE ADVERSE EVENT COULD BE THE RESULT OF AN ALLERGIC REACTION TO ETHYL CHLORIDE OR URTICARIA. GEBAUER WAS TOLD THE PT REQUIRED MEDICAL ATTENTION BUT NO INFO WAS PROVIDED AS TO WAT INTERVENTIONS WERE TAKEN. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN THE UNIT BACK AS WELL AS SEEK FURTHER INFO ON THE INJURY AND THE MEDICAL ATTENTION REQUIRED BUT WE WERE INFORMED THE PRODUCT WOULD NOT BE RETURNED AND NO FURTHER INFO WAS AVAILABLE.