MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-29 for LIVELY GREAT CALL MEDICAL ALERT 8637-20 manufactured by Great Call.
[146643269]
I have been using great call lively medical alert device only to learn it is defective and does not work yet the company (b)(6) and (b)(6) sells it and did not recall them. They told me today they have to admit in fact the device is faulty and defective and if i do not file a complaint they will give me all my money back and give me gift certificates at their (b)(6) stores to buy whatever i want if i return the device and do not tell anyone about the defects. Well you now know the devices are all defective and may have already caused deaths due to device not working as it did not work for me on two serious 911 calls for help. Medical device is defective. Fda safety report id # (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5086972 |
| MDR Report Key | 8654278 |
| Date Received | 2019-05-29 |
| Date of Report | 2019-05-24 |
| Date of Event | 2019-04-19 |
| Date Added to Maude | 2019-05-30 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT |
| 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 | LIVELY GREAT CALL MEDICAL ALERT |
| Generic Name | SYSTEM, COMMUNICATION, POWERED |
| Product Code | ILQ |
| Date Received | 2019-05-29 |
| Model Number | 8637-20 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GREAT CALL |
| Manufacturer Address | P.O. BOX 4428, CARLSBAD, CA 92018 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening; 2. Other; 3. Required No Informationntervention; 4. Deathisabilit | 2019-05-29 |