MAUDE Adverse Event Report: WAHL CLIPPER NINGBO LTD WAHL; 4295 MASSAGER

Device Problem Temperature Problem (3022)

Patient Problems Pain (1994); Full thickness (Third Degree) Burn (2696)

Event Date 02/09/2020

Event Type  Injury  

Manufacturer Narrative

We reviewed our temperature specifications for these massager attachments, and after receiving this report, we performed tests on our current stock of attachments.The test results fall within our temperature specifications.Both our pre-existing testing results and our new testing results range between 42-52 degrees c, which is in line with our requirements.The customer reported measuring a temperature of 126 degrees f, which is 52 degrees c and falls within our temperature specifications.We do not believe these massagers are defective.The massager attachment does not generate enough heat to cause the injury reported, unless the user has an underlying medical condition.Please see our product instructions and warnings for contraindications.

Event Description

Please see mw5093566.This response is provided for mw5093566.

• Brand Name: WAHL
• Type of Device: 4295 MASSAGER
• Manufacturer (Section D): WAHL CLIPPER NINGBO LTD; CH
• MDR Report Key: 10589696
• MDR Text Key: 208721257
• Report Number: 1410825-2020-00001
• Device Sequence Number: 1
• Product Code: ISA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial
• Report Date: 09/25/2020,03/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/25/2020
• Distributor Facility Aware Date: 03/09/2020
• Date Report to Manufacturer: 04/08/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization