MAUDE Adverse Event Report: CARDINAL HEALTH SHANGHAI CRUTCH AXILLARY YOUTH 52-62 300LB

Model Number CA901YTH

Device Problem Split (2537)

Patient Problem Fall (1848)

Event Date 11/06/2016

Event Type  Injury  

Manufacturer Narrative

A sample was not returned for investigation; therefore we are unable to determine the exact cause for the issue reported.Photos were provided that show that the crutch did break as reported, therefore confirming the issue reported, but we are unable to confirm the cause for the break.Sample of the failed device has been requested from the end user, but as of now has not been returned from the end user.If the sample is returned the investigation will be reopened.A review of the device history record for lot number 8400005271-sh showed no exceptions recorded that would have led to the reported incident.The supplier (b)(4) checked the (b)(4) materials and processing process as well as the assembly process and assembly workshop and no issues were found that would have contributed to the issue reported.We will continue to monitor for any similar reports.

Event Description

Based on the customer¿s husbands statement, the metal where the height is adjusted on the crutch split causing his wife to fall. he stated she only uses them when she transitions from a knee walker to a recliner and she only takes two "baby steps." when the crutch split she fell forward and hit her head on a dresser that is in the room and split her head open.  emt¿s were called and she was transported to (b)(6) hospital.She suffered a mild neck sprain, banged her bad foot on the floor and received six stitches for the wound on her head.

• Brand Name: CRUTCH AXILLARY YOUTH 52-62 300LB
• Type of Device: CRUTCH
• Manufacturer (Section D): CARDINAL HEALTH SHANGHAI; f20, tower 1, kerry everbright; shanghai 20007 0; CH 200070
• Manufacturer (Section G): CARDINAL HEALTH SHANGHAI; f20, tower 1, kerry everbright; shanghai 20007 0; CH 200070
• Manufacturer Contact: michele donatich ; 1500 waukegan rd; waukegan, IL 60085
• MDR Report Key: 6154560
• MDR Text Key: 61729792
• Report Number: 1423537-2016-00062
• Device Sequence Number: 1
• Product Code: IPR
• UDI-Device Identifier: 10885380050374
• UDI-Public: 10885380050374
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/08/2016

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?: No
• Device Operator: Other
• Device Model Number: CA901YTH
• Device Catalogue Number: CA901YTH
• Device Lot Number: 8400005271SH
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/08/2016
• Distributor Facility Aware Date: 11/10/2016
• Event Location: Home
• Date Report to Manufacturer: 11/10/2016
• Initial Date Manufacturer Received: 11/10/2016
• Initial Date FDA Received: 12/08/2016
• 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: 66 YR
• Patient Weight: 112