MAUDE Adverse Event Report: EXTERNAL FIXATOR DEVICE; SYSTEM, EXTERNAL FIXATOR (WITH METALLIC INVASIVE COMPONENTS)

Catalog Number UNKNOWN

Device Problem Unexpected Therapeutic Results (1631)

Patient Problem Tissue Damage (2104)

Event Date 09/12/2014

Event Type  Injury  

Event Description

Patient turned to the left side during chlorhexidine bath.External fixator device caused a gash in the medial aspect of left leg.Ccm aware and has viewed the skin alteration.Ccm states they will notify ortho.Charge nurse notified.Awaiting further orders from ccm or ortho.

• Brand Name: EXTERNAL FIXATOR DEVICE
• Type of Device: SYSTEM, EXTERNAL FIXATOR (WITH METALLIC INVASIVE COMPONENTS)
• MDR Report Key: 4284204
• MDR Text Key: 19762186
• Report Number: 4284204
• Device Sequence Number: 1
• Product Code: NDK
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 09/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Invalid Data
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/15/2014
• Event Location: Hospital
• Date Report to Manufacturer: 11/28/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/15/2014
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 79 YR