MAUDE Adverse Event Report: HOMEDICS HOMEDICS THERA-P MINI MASSAGER; HAND-HELD MASSAGER

Model Number PM-50A-9CTM-THP

Device Problem Packaging Problem (3007)

Patient Problem No Patient Involvement (2645)

Event Date 04/03/2016

Event Type  Other  

Event Description

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).

• Brand Name: HOMEDICS THERA-P MINI MASSAGER
• Type of Device: HAND-HELD MASSAGER
• Manufacturer (Section D): HOMEDICS ; 3000 pontiac trail ; commerce township MI 48390
• MDR Report Key: 5636698
• MDR Text Key: 44790683
• Report Number: MW5062120
• Device Sequence Number: 1
• Product Code: IPF
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: PM-50A-9CTM-THP
• Was Device Available for Evaluation?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1