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 |