DECORATIVE OFFSET CANE COMBO PACK 30006

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-05-16 for DECORATIVE OFFSET CANE COMBO PACK 30006 manufactured by Com-bridge International Co., Ltd.

Event Text Entries

[75307580] The end-user was using a cane in the bathroom, and the cane broke. The end-user fell, causing her to go to the hospital. The daughter states that her mother's back was bloody and bruised from the fall, and the daughter had to call 911. The daughter states her mother has been in the hospital since the fall - the user (her mother) fell on (b)(6) 2017. The daughter also states that her mother is unable to move her arms, and is still not stable enough to be released from hospital care. The dealer was able to provide some additional information: the end-user had been a customer of the dealer's for about 3-4 years, and is always returning products, and complaining to get free products from him. The dealer states that his customer only advised that her mother fell in the bathroom, and after he asked if the floor was wet, she refused to answer any further questions or provide additional information. The dealer was able to take pictures of the broken cane, but the daughter would not let him keep it, and it is still in the daughter's possession. The dealer also mentioned that he was not even sure that he was the one who sold the cane to the end-user, but since he carries so many roscoe products, he offered the end-user a free product from his store in exchange. The dealer did check the cane for a serial number, but a majority of the label was worn off. The dealer did not have exact information from the customer, but he states that the end-user is about 5'7", in her 70's maybe, (b)(6), and has a bad gait. This was all of the information the dealer was able to provide.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 3012316249-2017-00053
• MDR Report Key: 6571032
• Date Received: 2017-05-16
• Date of Report: 2017-05-16
• Date of Event: 2017-04-07
• Date Facility Aware: 2017-04-20
• Report Date: 2017-05-16
• Date Reported to FDA: 2017-05-16
• Date Reported to Mfgr: 2017-05-16
• Date Added to Maude: 2017-05-16
• Event Key: 0
• Report Source Code: Distributor report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 0
• Initial Report to FDA: 0
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: DECORATIVE OFFSET CANE COMBO PACK
• Generic Name: CANE
• Product Code: IPS
• Date Received: 2017-05-16
• Model Number: 30006
• Catalog Number: 30006
• Operator: LAY USER/PATIENT
• Device Availability: N
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: COM-BRIDGE INTERNATIONAL CO., LTD
• Manufacturer Address: UNIT 1, NO 66 YU LONG 3 ROAD DONG SHENG TOWN ZHONG SHAN CITY, 528414 CH 528414

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2017-05-16