MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-10 for PHARMCHEK DRUG PATCH manufactured by Pharmchem, Inc..
[145021504]
Pt called to report problem with her pharmchek drug patch. Pt stated that she wears the patch for drug use testing, and she has received false positive results when she was not using drugs.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5086566 |
| MDR Report Key | 8604576 |
| Date Received | 2019-05-10 |
| Date of Report | 2018-12-11 |
| Date of Event | 2018-09-01 |
| Date Added to Maude | 2019-05-13 |
| 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 |
| 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 | PHARMCHEK DRUG PATCH |
| Generic Name | CONTAINER, SPECIMEN, STERILE |
| Product Code | FMH |
| Date Received | 2019-05-10 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PHARMCHEM, INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-10 |