MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-05-05 for SONIC CARE PERSONAL MASSAGER 133804A manufactured by Smart Circle International Www.s.
[44835374]
Husband was using sonic comfort personal massager and suffered large 1st degree burns on his back, requiring him to seek medical care within 2 hours. The product brochure inside did not come with instructions, nor safety warning. He was treated at a walk in clinic with silver nitrate ointment.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5062139 |
| MDR Report Key | 5640723 |
| Date Received | 2016-05-05 |
| Date of Report | 2016-05-05 |
| Date of Event | 2016-02-25 |
| Date Added to Maude | 2016-05-09 |
| 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 FAMILY MEMBER OR FRIEND |
| 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 | SONIC CARE PERSONAL MASSAGER |
| Generic Name | MASSAGER |
| Product Code | ISA |
| Date Received | 2016-05-05 |
| Model Number | 133804A |
| Lot Number | 1653040 27415 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMART CIRCLE INTERNATIONAL WWW.S |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-05-05 |