MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-05-04 for HOMEDICS THERA-P MINI MASSAGER PM-50A-9CTM-THP manufactured by Homedics.
[44790683]
The consumer indicates that the hand-held massager has a (b)(6) warning label on it that she did not notice until she bought and opened the product. The consumer believe if a product is known to cause reproductive toxicity and / or harm that it should not be sold to consumers. The consumers also believes that if the state of (b)(6) requires the (b)(6) warning label on products, that all states should require it too. The consumer plans on returning the product to the retailer. Us. Retailer: (b)(6). Retailer state: (b)(6). The product was not damaged before the incident. The product was not modified before the incident. If not, do you plan to contact them: yes. Purchase date: (b)(6) 2016. (b)(6). (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5062120 |
| MDR Report Key | 5636698 |
| Date Received | 2016-05-04 |
| Date of Report | 2016-04-04 |
| Date of Event | 2016-04-03 |
| Date Added to Maude | 2016-05-06 |
| 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 |
| 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 | HOMEDICS THERA-P MINI MASSAGER |
| Generic Name | HAND-HELD MASSAGER |
| Product Code | IPF |
| Date Received | 2016-05-04 |
| Model Number | PM-50A-9CTM-THP |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HOMEDICS |
| Manufacturer Address | 3000 PONTIAC TRAIL COMMERCE TOWNSHIP MI 48390 US 48390 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-05-04 |