MAUDE Adverse Event Report: WITHINGS S.A. WITHINGS PULSEHR (NEW); OXIMETER

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Superficial (First Degree) Burn (2685); Skin Disorders (4543)

Event Date 11/03/2021

Event Type  Injury  

Event Description

Purchased withings health fitness tracker pulsehr and started wearing the tracker.After 6 months of wearing start feeling irritation on wrist where the tracker was worn and disappeared in few days- figured might be just my thinking- washed with water throughly and started wearing again- after a 3-4 weeks of time i start having same irritation skin issue- i was cleaning tracker periodically.I started seeing some burn marks on my skin with blood coming out.I took tracker and wore on other hand just to make sure.I started feeling the same way at other hand.I was sure that there is some type of radiation happening.I took watch out and send the email to withings and requested investigation on it.I also send them pictures of my wrist.They reply that its most likely cleaning issue and we don't have cases like that.I told them my hand is burnt and i am cleaning this tracker regularly.At the end they offer me refund.They don't think it's important for them to put some effort on it and find out there might be issue with there tracker.Fda safety report id# (b)(4).

• Brand Name: WITHINGS PULSEHR (NEW)
• Type of Device: OXIMETER
• Manufacturer (Section D): WITHINGS S.A.
• MDR Report Key: 13118295
• MDR Text Key: 283103443
• Report Number: MW5106373
• Device Sequence Number: 1
• Product Code: DQA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 12/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/29/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 46 YR
• Patient Sex: Male
• Patient Weight: 75 KG
• Patient Ethnicity: Non Hispanic