MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-12-16 for BROOKSTONE MAX 2 DUAL NODE MASSAGER manufactured by Brookstone.
[33995543]
Incident while using personal massager, a brookstone max 2 dual node massager on his neck, consumer suffered stroke and had to be hospitalized. Retailer: (b)(6). Purchase date: (b)(6) 2014, this date is an estimate. The product was not damaged before the incident. The product was not modified before the incident. Sent information regarding injury to (b)(6). Document number: (b)(4). Report number: (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5058587 |
| MDR Report Key | 5311042 |
| Date Received | 2015-12-16 |
| Date of Report | 2015-12-02 |
| Date of Event | 2015-06-03 |
| Date Added to Maude | 2015-12-18 |
| 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 | BROOKSTONE |
| Generic Name | BROOKSTONE MAX 2 DUAL NODE MASSAGER - PERSONAL MASSAGER |
| Product Code | ISA |
| Date Received | 2015-12-16 |
| Model Number | MAX 2 DUAL NODE MASSAGER |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BROOKSTONE |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-12-16 |