MAUDE Adverse Event Report: MEDSOURCE INTERNATIONAL LLC CURAPLEX; TRANSPORTER CHAIR

Model Number	3246-95206
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Unspecified Musculoskeletal problem (4535)
Date of Event	07/25/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Paramedics opened new transport chair and attempted to lift patient that is described as 230-240lbs when patient was placed in chair and attempt to lift and move to stair chair the transport chair ripped down the middle seam, causing the patient to drop and the medic catching the patient cause their arm to be injured, and he was placed off work.Investigation results: this product was produced prior to a product design change that was put in place to mitigate this matter.
Event or Problem Description
Paramedics opened new transport chair and attempted to lift patient that is described as 230-240lbs when patient was placed in the chair and they attempted to lift and move the transporter chair, the transport chair ripped down the middle seam, causing the patient to drop.The medic caught the patient to ease the fall.The medic's arm was injured, and he was placed off work.

• Brand Name: CURAPLEX
• Common Device Name: TRANSPORTER CHAIR
• Manufacturer (Section D): MEDSOURCE INTERNATIONAL LLC; 8600 shelby court; chanhassen MN 55317
• Manufacturer Contact: lisa fan ; no.88 anhua road; anchang industrial zone; shaoxing, zhejiang 31208-0 ; CH 312080
• MDR Report Key: 17628203
• Report Number: 3003674698-2023-00453
• Device Sequence Number: 14986393
• Product Code: FMR
• UDI-Device Identifier: 00810071631467
• UDI-Public: 00810071631467
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/27/2023

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
• Operator of Device: Health Professional
• Device Model Number: 3246-95206
• Device Lot Number: 1504693
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2023
• Initial Report FDA Received Date: 08/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/10/2022
• 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
• Patient Sequence Number: 1
• Patient Sex: Male