MAUDE Adverse Event Report: HOMECARE CO. LTD ENDURANCE FOLDING SEAT CANE

Model Number 6053

Device Problems Component(s), broken (1103); Fracture (1260)

Patient Problems Fall (1848); No Consequences Or Impact To Patient (2199)

Event Date 08/01/2014

Event Type  malfunction  

Event Description

(b)(4) dealer states that end user returned a broken three legged seat cane stating that one of the legs broke on the first use.No identifying info was gathered by the dealer for this cash sale.End user reported falling without injury.Upon inspection the rear leg is broken at the hinge which connects the three legs.

• Brand Name: ENDURANCE FOLDING SEAT CANE
• Type of Device: SEAT CANE
• Manufacturer (Section D): HOMECARE CO. LTD; no. 11, chang sheng st; huatan township changhua county, r.o.c. 503 ; TW 503
• MDR Report Key: 4071911
• MDR Text Key: 4897112
• Report Number: 1056127-2014-00015
• Device Sequence Number: 1
• Product Code: IPS
• 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: 08/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 6053
• Device Catalogue Number: W1450
• 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: 08/26/2014
• Distributor Facility Aware Date: 08/04/2014
• Device Age: 17 MO
• Event Location: Other
• Date Report to Manufacturer: 08/22/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Weight: 90