BROOKSTONE MAX 2 DUAL NODE MASSAGER

MAUDE Adverse Event Report

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.

Event Text Entries

[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


MAUDE Entry Details

Report NumberMW5058587
MDR Report Key5311042
Date Received2015-12-16
Date of Report2015-12-02
Date of Event2015-06-03
Date Added to Maude2015-12-18
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPATIENT FAMILY MEMBER OR FRIEND
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameBROOKSTONE
Generic NameBROOKSTONE MAX 2 DUAL NODE MASSAGER - PERSONAL MASSAGER
Product CodeISA
Date Received2015-12-16
Model NumberMAX 2 DUAL NODE MASSAGER
Device Availability*
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerBROOKSTONE


Patients

Patient NumberTreatmentOutcomeDate
10 2015-12-16

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