MAUDE Adverse Event Report: CARDINAL SCALE MFG. CO. DETECTO STADIOMETER SCALE

Model Number 439

Device Problems Mechanical Problem (1384); Mechanics Altered (2984)

Patient Problem Injury (2348)

Event Date 07/15/2016

Event Type  Injury  

Event Description

The patient used the stadiometer rod to stabilize herself.The stadiometer rod was not lowered to its lowest position.The top of the rod has a metal plate that does have a sharp edge.As the patient was reaching for the stadiometer to stabilize herself she grabbed this portion of the rod and came into contact with the sharp edge.Cautery required to stop bleeding.

• Brand Name: DETECTO STADIOMETER SCALE
• Type of Device: SCALE
• Manufacturer (Section D): CARDINAL SCALE MFG. CO.; 203 east daugherty; webb city MO 64870
• MDR Report Key: 5842686
• MDR Text Key: 51021396
• Report Number: 5842686
• Device Sequence Number: 1
• Product Code: MNW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 439
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/25/2016
• Device Age: 8 YR
• Date Report to Manufacturer: 07/25/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO
• Patient Outcome(s): Other; Required Intervention