MAUDE Adverse Event Report: BSN MEDICAL INC. AO CAST SAW; INSTRUMENT, CAST REMOVAL, AC-POWERED

Model Number 0295-200

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Code Available (3191)

Event Date 03/29/2018

Event Type  malfunction  

Event Description

Cast saw malfunctioned and cut the patient's skin.

• Brand Name: AO CAST SAW
• Type of Device: INSTRUMENT, CAST REMOVAL, AC-POWERED
• Manufacturer (Section D): BSN MEDICAL INC.; 5825 carnegie blvd; charlotte NC 28209
• MDR Report Key: 7453806
• MDR Text Key: 106266462
• Report Number: 7453806
• Device Sequence Number: 1
• Product Code: LGH
• 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: 04/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 09/01/2018
• Device Model Number: 0295-200
• Device Lot Number: 74470-10
• Other Device ID Number: MEDICAL ENGINEERING CONTROL #
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/18/2018
• Event Location: Other
• Date Report to Manufacturer: 04/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 52 YR