MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-04-12 for POLIGRIP - SUPER STRONG manufactured by .
[15500340]
I have used poligrip and my hand start tingling and numbness from my left arm down to my finger. But i went to the doctor and they could not find anything. And then my heart starting beating fast when i lay down to sleep and i have to get up for a while. Dose or amount: 2 doses a day, frequency: everyday. Diagnosis or reason for use: denture. Event abated after use: yes. Event reappeared after reintroduction: yes.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5015528 |
| MDR Report Key | 1658769 |
| Date Received | 2010-04-12 |
| Date of Report | 2010-02-28 |
| Date of Event | 2009-03-28 |
| Date Added to Maude | 2010-04-19 |
| 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 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | POLIGRIP - SUPER STRONG |
| Generic Name | SUPER STRONG |
| Product Code | KOQ |
| Date Received | 2010-04-12 |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2010-04-12 |