MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-03-24 for HEALTHMARKER TIME TEMPERATURE INDICATOR manufactured by Temptime Corporation.
[71219515]
Notified of recent hospitalization from insurance claims. Diagnosis for admission: g40. 909 - epilepsy uns not intract w/o status epilepticus. Diagnosis or reason for use: r62. 52. Is the product compounded: no. Is the product over-the-counter: no.
Patient Sequence No: 1, Text Type: D, B5
Report Number | MW5068723 |
MDR Report Key | 6442345 |
Date Received | 2017-03-24 |
Date of Report | 2017-03-24 |
Date of Event | 2017-03-16 |
Date Added to Maude | 2017-03-29 |
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 | 3 |
Health Professional | 3 |
Initial Report to FDA | 3 |
Report to FDA | 3 |
Event Location | 3 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 0 |
Brand Name | HEALTHMARKER TIME TEMPERATURE INDICATOR |
Generic Name | TRANS TRACKER F (HEAT) |
Product Code | OCI |
Date Received | 2017-03-24 |
Device Availability | N |
Device Eval'ed by Mfgr | I |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | TEMPTIME CORPORATION |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2017-03-24 |