MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. CRUTCHES; TIPS AND PADS, CANE, CRUTCH AND WALKER

Model Number MDSV80535

Device Problems Detachment Of Device Component (1104); Material Separation (1562)

Patient Problem No Information (3190)

Event Date 02/17/2015

Event Type  malfunction  

Event Description

The therapist was in front of the patient and the assistant in the back of the patient.Patient was using the rail and a crutch on the steps, coming down, and the crutch came apart.The top rubber and aluminum separated from the whole crutch.The crutches were new and had just been opened in the morning pt visit and were just fine at the time.The patient's weight was less than 100 lbs.The rehab assistant who completed this report has been here for several years.
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manufacturer response for aluminum crutch, medline (per site reporter).
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i talked to quality and said i had the crutch to send back.They asked me to send a picture and i told him i wanted to send the actual crutch for investigation.They are sending me a shipping label.

• Brand Name: CRUTCHES
• Type of Device: TIPS AND PADS, CANE, CRUTCH AND WALKER
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; one medline pl.; mundelein IL 60060
• MDR Report Key: 4634683
• MDR Text Key: 5594819
• Report Number: 4634683
• Device Sequence Number: 1
• Product Code: INP
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 02/19/2015

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: Other
• Device Model Number: MDSV80535
• Device Lot Number: 140866702
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/19/2015
• Event Location: Hospital
• Date Report to Manufacturer: 03/26/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/19/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NO OTHER THERAPIES