MAUDE Adverse Event Report: MEDSOURCE INTERNATIONAL LLC CURAPLEX FITTED STRETCHER SHEET; CURAPLEX XPS FITTED STRETCHER SHEET, 36 X 90

Model Number	3271-62602
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/14/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Directly from the customer: "i learned we have one guy off on injury for having to catch a patient because one of these sheets tore while transferring a patient at the hospital.".
Additional Manufacturer Narrative
Root cause: due to a supplier change (vietnam to colombia) both medsource and the private label customer were under the impression the product was would not affect tensile strength.However, after further comparison of the products from the original manufacturer to the current, it was found that the colombia sheets had a different manufacturing process for the seams that reduced tensile strength, thus resulting in the product ripping easily if used for patient transport.Corrective action: ronexmed (colombia supplier) will update manufacturing for the xps sheet by improving the tensile strength formulation and heading process, as well as increasing the gsm (grams per square metre) providing additional fabric thickness to assistant in mitigating tears during use.Health hazard evaluation was conducted and it was found that no additional action is required by medsource at this time.

• Brand Name: CURAPLEX FITTED STRETCHER SHEET
• Common Device Name: CURAPLEX XPS FITTED STRETCHER SHEET, 36 X 90
• Manufacturer (Section D): MEDSOURCE INTERNATIONAL LLC; 8600 shelby court; chanhassen MN 55317
• Manufacturer Contact: elias daffach ; cl 81 no. 56 - 21; barranquilla, atlantico 08001-2 ; CO 080012
• MDR Report Key: 17367623
• Report Number: 3003674698-2022-00007
• Device Sequence Number: 15304951
• Product Code: FMR
• UDI-Device Identifier: 00810071633331
• UDI-Public: 00810071633331
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Modification/Adjustment
• Type of Report: Initial
• Report Date (Section B): 10/06/2022

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: 3271-62602
• Device Catalogue Number: 3271-62602
• Device Lot Number: 1504736
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/14/2022
• Initial Report FDA Received Date: 07/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/08/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown