MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-06-21 for MEDICOOLER MICRO REFRIGERATOR manufactured by Medicool, Inc.
[3472590]
Purchased a medicooler advertised as a portable cooling unit that operates from 110-120v ac or 12v dc current. The first unit received was defective and stopped operation after 30 minutes. The replacement unit actually heated my insulin after 4 hours of operation resulting in an emergency situation on an extended road trip. My insulin was not suitable for use. I am a diabetic and rely on insulin to stabilize my blood sugar. Purchase date: (b)(6) 2013. I wrote the manufacturer a letter letting them know the unit was defective. Document number: (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5030652 |
| MDR Report Key | 3193362 |
| Date Received | 2013-06-21 |
| Date of Report | 2013-06-07 |
| Date of Event | 2013-05-30 |
| Date Added to Maude | 2013-06-28 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | PATIENT |
| Health Professional | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MEDICOOLER MICRO REFRIGERATOR |
| Generic Name | PORTABLE MEDICAL SUPPLY REFRIGERATION UNIT |
| Product Code | LDQ |
| Date Received | 2013-06-21 |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDICOOL, INC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-06-21 |