MAUDE Adverse Event Report: CUSTOM SCALE SOLUTIONS INC DIGITAL SCALE; DIGITAL SCALE FOR PATIENT LIFT

Model Number 59011A

Device Problem Material Separation (1562)

Patient Problem Fall (1848)

Event Date 11/16/2017

Event Type  Injury  

Manufacturer Narrative

The scale was attached to the hpl402 lift.See below for product information: (b)(4).(b)(6).Model#: hpl402, catalog#: hpl402, (b)(4).Health professional.

Event Description

It was reported to the manufacturer by the end user, per the end user, "the patient was being lifted over her bed and the whole screw along with the cradle came down and dropped her.She cut her head on the headboard and had to go to the hospital for stitches.The cradle also fell on her and gave her bruising." (b)(4) and (b)(4) were entered into our system to have the lift scale returned to joerns for investigation.As of this writing, the lift scale has not been returned.

• Brand Name: DIGITAL SCALE
• Type of Device: DIGITAL SCALE FOR PATIENT LIFT
• Manufacturer (Section D): CUSTOM SCALE SOLUTIONS INC; 570 rock road dr ste h; east dundee IL 60118
• Manufacturer (Section G): CUSTOM SCALE SOLUTIONS INC; 570 rock road dr ste h; east dundee IL 60118
• Manufacturer Contact: felicia banks ; 2100 design road; arlington, TX 76014 ; 8008260270
• MDR Report Key: 7067800
• MDR Text Key: 93245217
• Report Number: 3009402404-2017-00057
• Device Sequence Number: 1
• Product Code: FSA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Service Personnel
• Type of Report: Initial
• Report Date: 11/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 59011A
• Device Catalogue Number: 59011A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/17/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 90 YR
• Patient Weight: 54