MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-08-01 for SHIATSU MASSAGE PILLOW WITH HEAT 198459 manufactured by Homedics.
[4633130]
I used the shiatsu massage pillow as i had in the past. I set the shiatsu massage pillow at the top of a stack of inclined pillows on my bed. My neck was gently resting on the pillow. Less than 10 minutes into the massage, my neck started to burn. It had rubbed off my skin. The painful abrasion was the size of a quarter. In the morning, the pain became worse and the abrasion started to ooze and bleed. I could not turn my neck from left to right or look up or down without opening the abrasion. My physician recommended that i continue to apply an antibiotic ointment to prevent an infection. It took the abrasion over 3 weeks to heal. I still have a scar one year later. Homedics does not take this matter seriously. They do not respond in a timely manner. It has taken a over a month to get a response by email. They do not return calls, and are ignoring my demand for compensation. Serious skin abrasion that caused a scar.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5037619 |
| MDR Report Key | 3983532 |
| Date Received | 2014-08-01 |
| Date of Report | 2014-07-21 |
| Date of Event | 2013-04-20 |
| Date Added to Maude | 2014-08-07 |
| 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 | PATIENT |
| Health Professional | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SHIATSU MASSAGE PILLOW WITH HEAT |
| Generic Name | MASSAGE PILLOW WITH HEAT |
| Product Code | ISA |
| Date Received | 2014-08-01 |
| Model Number | 198459 |
| Operator | LAY USER/PATIENT |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HOMEDICS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-08-01 |