MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-09-25 for PSA HOME MICRO PROSTATE CANCER TEST manufactured by Pinnacle Labs.
[87481662]
Used pinnacle biolabs med device to take at home psa test. The device to puncture the skin was defective, reached out 3 times in as many weeks to customer service contact info, received no reply.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5072427 |
| MDR Report Key | 6893985 |
| Date Received | 2017-09-25 |
| Date of Report | 2017-09-23 |
| Date of Event | 2017-09-02 |
| Date Added to Maude | 2017-09-26 |
| 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 | PSA HOME MICRO PROSTATE CANCER TEST |
| Generic Name | PROSTATE SPECIFIC ANTIGEN |
| Product Code | LTJ |
| Date Received | 2017-09-25 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PINNACLE LABS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-09-25 |