MAUDE Adverse Event Report: COM-BRIDGE INTERNATIONAL CO., LTD. ENDURANCE FOREARM CRUTCH

Model Number ST601A

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

Pt told dealer that he had noticed that a cuff on one of the pair of his forearm crutches was loose and he continued to use it until it separated completely.When the crutches were returned to the dealer one of the pair did show the separation.There was no similar problem with the second.

• Brand Name: ENDURANCE FOREARM CRUTCH
• Type of Device: FOREARM CRUTCH
• Manufacturer (Section D): COM-BRIDGE INTERNATIONAL CO., LTD.; no. 50 yong hua road; dong shen town; zhong shan city, guang dong province ; CH
• MDR Report Key: 3713735
• MDR Text Key: 4252920
• Report Number: 1056127-2014-00004
• Device Sequence Number: 1
• Product Code: INP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: Unknown
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/18/2014,02/20/2014

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
• Device Operator: Lay User/Patient
• Device Model Number: ST601A
• Device Catalogue Number: W4102
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/18/2014
• Distributor Facility Aware Date: 02/20/2014
• Device Age: 4 YR
• Event Location: Other
• Date Report to Manufacturer: 03/17/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/18/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 31 YR
• Patient Weight: 61