MAUDE Adverse Event Report: OWENS & MINOR DISTRIBUTION, INC. MEDICHOICE ALUMINUM CRUTCHES 5'2 - 5'10

Catalog Number 77708A

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Fall (1848)

Event Date 09/24/2015

Event Type  malfunction  

Event Description

Following discharge from the emergency room, the wing nut on one of the patient's crutches came loose on the hand grip, came out, causing the patient to fall onto her right side.Manufacturer response for crutches, medichoice aluminum crutches 5'2 - 5'10 (per site reporter): contacted field rep.Received return call from manufacturer requesting po # in order to provide ra for return.States that determination will be made whether or not an investigation of device will occur.

• Brand Name: MEDICHOICE ALUMINUM CRUTCHES 5'2 - 5'10
• Type of Device: CRUTCHES
• Manufacturer (Section D): OWENS & MINOR DISTRIBUTION, INC.; 9120 lockwood blvd.; mechanicsville VA 23116
• MDR Report Key: 5376150
• MDR Text Key: 36236375
• Report Number: 5376150
• Device Sequence Number: 1
• Product Code: IPR
• 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: 01/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2016
• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 77708A
• Device Lot Number: CM1502 037576
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/14/2016
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 01/14/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 53 YR
• Patient Weight: 68