MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; K3 BASIC, 20", ADJ,DLA,S/A FT,ANTI-TIP

Catalog Number MDS806660EPL

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem Fall (1848)

Event Date 05/01/2018

Event Type  Injury  

Manufacturer Narrative

It was reported that while self-propelling with his hands and feet, the right front wheel of the wheelchair broke off and the end-user experienced a fall.The end-user fell onto his left side onto the tile floor of a bathroom.Paramedics were called and the end-user was taken to a hospital emergency department for evaluation.The end-user received x-ray imaging to his right arm and his right hip.No fractures were identified.No additional diagnostics reported.The end-user was given unidentified medication for pain control.No other treatments reported.The end-user was admitted to the hospital for overnight observation.The admitting diagnosis was not reported.Reportedly, the end-user experienced bruising "to both sides" and a hematoma and a blister to his right hip.No sample was returned to the manufacturer for evaluation.Due to the reported incident, and in an abundance of caution, this medwatch is being filed.If additional relevant information becomes available a supplemental medwatch will be filed.

Event Description

It was reported that while self-propelling with his hands and feet, the right front wheel of the wheelchair broke off and the end-user experienced a fall.The end-user was reportedly admitted to a hospital for overnight observation.

• Type of Device: K3 BASIC, 20", ADJ,DLA,S/A FT,ANTI-TIP
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: nigel vilches ; three lakes drive; northfield, IL 60093-2753 ; 2249311458
• MDR Report Key: 7590719
• MDR Text Key: 110718061
• Report Number: 1417592-2018-00045
• Device Sequence Number: 1
• Product Code: IOR
• UDI-Device Identifier: 00888277363000
• UDI-Public: 888277363000
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: MDS806660EPL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/18/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 63 YR
• Patient Weight: 115