MAUDE Adverse Event Report: ZHONGSHAN A&E MACHINERY INDUSTRY CO. LTD LUMEX IMPERIAL COLLECTION; DUAL RLEASE X-WIDE FOLDING WALKER

Model Number 604070A

Device Problem Break (1069)

Patient Problems Fall (1848); Hemorrhage, Cerebral (1889)

Event Date 06/14/2019

Event Type  Injury  

Manufacturer Narrative

Third party testing has been requested.A follow-up report will be sent in the event the product subject to this adverse event is returned and a failure analysis performed.

Event Description

On (b)(6) 2019 a medical equipment dealer/distributor delivered a rental bariatric walker with wheels per physician's order to lafayette rehabilitation.Same day the dealer was notified that one of the wheels was too tight and did not roll.The technician returned to the facility and adjusted the wheel.After patient's discharge on (b)(6) 2019, a member of the patient's family called the dealer stating the wheel failed on the walker.No mention of a fall or injury.The dealer instructed the family member to bring the walker in on monday as it was 5:00 pm and the dealer was closed.On or about (b)(6) 2019, the medical equipment dealer received a letter from an attorney stating on (b)(6) 2019 their client sustained injuries in an incident which occurred as a result of a defective walker provided to patient/client.On (b)(6) 2019, patient's attorney returned importer's call stating the walker wheel broke off.The patient's fall resulted in cerebral bleeding and delayed the patient's chemoradiation therapy.

Manufacturer Narrative

Attachment: [ats findings 12-10-2019_001.Pdf].

Event Description

On (b)(6) 2019 a medical equipment dealer/distributor delivered a rental bariatric walker with wheels per physician's order to lafayette rehabilitation.Same day the dealer was notified that one of the wheels was too tight and did not roll.The technician returned to the facility and adjusted the wheel.After patient's discharge on (b)(6) 2019, a member of the patient's family called the dealer stating the wheel failed on the walker.No mention of a fall or injury.The dealer instructed the family member to bring the walker in on monday as it was 5:00 pm and the dealer was closed.On or about (b)(6) 2019, the medical equipment dealer received a letter from an attorney stating on (b)(6) 2019 their client sustained injuries in an incident which occurred as a result of a defective walker provided to patient/client.On (b)(6) 2019, patient's attorney returned importer's call stating the walker wheel broke off.The patient's fall resulted in cerebral bleeding and delayed the patient's chemoradiation therapy.

• Brand Name: LUMEX IMPERIAL COLLECTION
• Type of Device: DUAL RLEASE X-WIDE FOLDING WALKER
• Manufacturer (Section D): ZHONGSHAN A&E MACHINERY INDUSTRY CO. LTD; zhongshan city, 51000 0; CH 510000
• MDR Report Key: 8906157
• MDR Text Key: 154739879
• Report Number: 2428983-2019-00003
• Device Sequence Number: 1
• Product Code: ITJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial,Followup
• Report Date: 08/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 604070A
• Device Lot Number: AEU226MO
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/19/2019
• Distributor Facility Aware Date: 07/22/2019
• Device Age: 6 MO
• Event Location: Other
• Date Report to Manufacturer: 08/16/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/19/2019
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 54 YR
• Patient Weight: 150