MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-12-22 for NUTRIMOST manufactured by .
[20297274]
Pt suffered a cardiac arrest while on the nutrimost diet system. Her serum potassium was 2. 2 meg/l when first measured. Dates of use: (b)(6) 2014. Diagnosis or reason for use: weight loss.
Patient Sequence No: 1, Text Type: D, B5
Report Number | MW5039813 |
MDR Report Key | 4368312 |
Date Received | 2014-12-22 |
Date of Report | 2014-12-22 |
Date of Event | 2014-12-16 |
Date Added to Maude | 2014-12-31 |
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 | PHARMACIST |
Health Professional | 3 |
Initial Report to FDA | 3 |
Report to FDA | 3 |
Event Location | 0 |
Single Use | 0 |
Previous Use Code | 0 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | NUTRIMOST |
Generic Name | DIET SYSTEM |
Product Code | GZO |
Date Received | 2014-12-22 |
Device Availability | N |
Device Sequence No | 1 |
Device Event Key | 0 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Death | 2014-12-22 |