MAUDE Adverse Event Report: CARDINAL HEALTH SHANGHAI CRUTCH AXILLARY TALL 70-78 300LB

Model Number	CA901TL
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Fall (1848); No Known Impact Or Consequence To Patient (2692)
Date of Event	08/04/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Without the lot number, the device history report could not be reviewed to determine if there was any exception that could lead to the reported incident.From the review of the production and quality inspection data for the past 12 months, no incident of crutch breakage of the hand grip tube area were recorded.The sample was not returned for investigation, however photos of the sample were provided.From the photos of the crutch, the break was confirmed.However, the cause of the breakage could not be derived from the photos.Without the sample we are not able to conduct a further evaluation to determine the actual cause of the broken crutch.Therefore the root cause could not be determined.
Event or Problem Description
Crutch broke.

• Brand Name: CRUTCH AXILLARY TALL 70-78 300LB
• Common Device Name: CRUTCH
• Manufacturer (Section D): CARDINAL HEALTH SHANGHAI; f20, tower 1, kerry everbright; shanghai 20007 0; CH 200070
• MDR Report Key: 5932419
• Report Number: 1423537-2016-00041
• Device Sequence Number: 814654
• Product Code: IPR
• UDI-Device Identifier: 10885380050398
• UDI-Public: 10885380050398
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: CA901TL
• Device Catalogue Number: CA901TL
• Device Lot Number: DIDN'T HAVE
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 08/09/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/09/2016
• Initial Report FDA Received Date: 09/07/2016
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other