MAUDE Adverse Event Report: UNKNOWN SCALE FOR WEIGHT SCALE, PATIENT

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/01/2018

Event Type  No Answer Provided  

Event Description

My blood pressure machine and scale to measure my weight is giving me inaccurate readings.

• Brand Name: SCALE FOR WEIGHT
• Type of Device: SCALE, PATIENT
• Manufacturer (Section D): UNKNOWN; unk
• MDR Report Key: 7813003
• MDR Text Key: 118393004
• Report Number: MW5079363
• Device Sequence Number: 0
• Product Code: FRW
• 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: 08/23/2018
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2018

Device Operator

• Was Device Available for Evaluation?: No Answer Provided
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information

Was Device Evaluated by Manufacturer?

Is the Device Single Use?

Is This a Reprocessed and Reused Single-Use Device?

Type of Device Usage

Patient Treatment Data

Date Received: 08/23/2018 Patient Sequence Number: 1