MAUDE Adverse Event Report: JIANGSU RIXIN MEDICAL EQUIPMENT CO., LTD CURAPLEX SCOOP STRETCHER; FOLDING SCOOP STRETCHER

Model Number	14781
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The locking mechanism did not perform as expected during use causing the latch to open when weight was applied and the latch was depressed.Performance of the locking mechanism within the latch was evaluated during simulated use.The same result was able to be replicated during the simulated use testing.
Event or Problem Description
Folding scoop stretcher latches are opening when weight is applied to the stretcher and the latch is depressed.This was brought to our attention by a feedback received stating that the patient was being carried down the stairs and they slid down and depressed the latch with their feet causing it to open.
Additional Manufacturer Narrative
It was deemed that the scoop stretcher was being used off label, as the stretcher is designed to be used on a flat surface.There was a latch cover that was created and offered to end users currently possessing this product as an optional accessory in the event that it is used off label.The latch cover underwent product testing and approval before being offered to end users.The scoop stretcher latch design was changed with the intention to prevent any future incidents in which the latch could be accidentally depressed.The product change underwent testing procedures before the product change was implemented.

• Brand Name: CURAPLEX SCOOP STRETCHER
• Common Device Name: FOLDING SCOOP STRETCHER
• Manufacturer (Section D): JIANGSU RIXIN MEDICAL EQUIPMENT CO., LTD; yangjin road jinfeng town; zhangjiagang, jiangsu 21562 6; CH 215626
• Manufacturer Contact: sally wang ; yangjin road jinfeng; zhangjiagang, jiangsu 21562-6 ; CH 215626
• MDR Report Key: 17043772
• Report Number: 3003674698-2023-00345
• Device Sequence Number: 15201997
• Product Code: FPP
• UDI-Device Identifier: 00812277037401
• UDI-Public: 00812277037401
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/13/2023

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
• Operator of Device: Lay User/Patient
• Device Model Number: 14781
• Device Catalogue Number: 14781
• Device Lot Number: 1504872
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/08/2023
• Supplement Date Received by Manufacturer: 02/08/2023
• Initial Report FDA Received Date: 06/01/2023
• Supplement Report FDA Received Date: 09/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/10/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown