MAUDE Adverse Event Report: AMATECH SKYTRON ; STIRRUP

Catalog Number 4-090-03-1

Device Problem Insufficient Information (3190)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  Injury  

Event Description

This is a response to mw5042607.(b)(4) has reached out to the facility and have not been able to gather more information regarding the incident.Report shows that the product was disposed of.Investigation cannot continue without further information.

• Brand Name: SKYTRON
• Type of Device: STIRRUP
• Manufacturer (Section D): AMATECH; acton MA
• Manufacturer (Section G): SKYTRON, DIV. THE KMW GROUP, INC.; 5000 36th st., s.e.; grand rapids MI 49512
• Manufacturer Contact: 5000 36th st., s.e.; grand rapids, MI 49512
• MDR Report Key: 5064418
• MDR Text Key: 25319025
• Report Number: 1825014-2015-00037
• Device Sequence Number: 1
• Product Code: OSI
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Nurse
• Report Date: 09/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2015
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 4-090-03-1
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/02/2015
• Distributor Facility Aware Date: 07/13/2015
• Event Location: Hospital
• Date Report to Manufacturer: 09/03/2015
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention