SCALE FOR WEIGHT

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-23 for SCALE FOR WEIGHT manufactured by Unknown.

Event Text Entries

[118393004] My blood pressure machine and scale to measure my weight is giving me inaccurate readings.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5079363
• MDR Report Key: 7813003
• Date Received: 2018-08-23
• Date of Report: 2018-08-23
• Date of Event: 2018-07-01
• Date Added to Maude: 2018-08-24
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 0
• Product Problem Flag: 0
• Reprocessed and Reused Flag: 3
• Reporter Occupation: PATIENT
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Sequence Number: 0

• Brand Name: SCALE FOR WEIGHT
• Generic Name: SCALE, PATIENT
• Product Code: FRW
• Date Received: 2018-08-23
• Device Availability: *
• Device Eval'ed by Mfgr: I
• Device Sequence No: 0
• Device Event Key: 0
• Manufacturer: UNKNOWN
• Manufacturer Address: UNK UNK

Device Sequence Number: 1

• Brand Name: BLOOD PRESSURE MONITOR
• Generic Name: SYSTEM MEASUREMENT BLOOD PRESSURE
• Product Code: DXN
• Date Received: 2018-08-23
• Device Availability: *
• Device Eval'ed by Mfgr: I
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: WELCH ALLYN, INC.

Device Sequence Number: 2

• Brand Name: SCALE FOR WEIGHT
• Generic Name: SCALE, PATIENT
• Product Code: FRW
• Date Received: 2018-08-23
• Device Availability: *
• Device Eval'ed by Mfgr: I
• Device Sequence No: 2
• Device Event Key: 0
• Manufacturer: UNK
• Manufacturer Address: UNK UNK

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2018-08-23