MAUDE Adverse Event Report: MEDSOURCE LABS CURAPLEX; QUICK CONNECT CARRIER

Model Number	3245-19123
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/30/2026
Type of Reportable Event	Malfunction
Event or Problem Description
There were two feedbacks submitted for the quick connect carrier (3245-19123).Both feedbacks involved the carrier breaking at a rivet point.In both instances there was a patient on the carrier, however neither incident involved an injury due to the breakage occuring when the patient was still very low to the ground.Due to the potential that an injury could have occured a report is being filed.Both incidents involved carriers with visible wear/scuff marks.Both carriers had 3-4 years of use.The lot number could not be identified for either incident.Feedbacks were initially reported to the distributor and then passed along to medsource.The initial feedback reporters to the distributor are as follows: fb 1254 gonzales co emerg 1703 n saint joseph st gonzales, tx 78629-2331.Fb 1269 audrian ambulance district 440 kelley pkwy mexico, mo 65265.
Additional Manufacturer Narrative
There were two feedbacks submitted for the quick connect carrier (3245-19123).Both feedbacks involved the carrier breaking at a rivet point.In both instances there was a patient on the carrier, however neither incident involved an injury due to the breakage occuring when the patient was still very low to the ground.Due to the potential that an injury could have occured a report is being filed.Both incidents involved carriers with visible wear/scuff marks.Both carriers had 3-4 years of use.Actual affected units were requested, but were not able to be provided per the time of this report.The lot number could not be identified for either incident.An investigation has been requested and is pending.Feedbacks were initially reported to the distributor and then passed along to medsource.The initial feedback reporters to the distributor are as follows: fb 1254 gonzales co emerg 1703 n saint joseph st gonzales, tx 78629-2331.Fb 1269 audrian ambulance district 440 kelley pkwy mexico, mo 65265.

• Brand Name: CURAPLEX
• Common Device Name: QUICK CONNECT CARRIER
• Manufacturer (Section D): MEDSOURCE LABS; 8600 shelby ct; suite 100; chanhassen MN 55317
• MDR Report Key: 25117134
• Report Number: 3003674698-2026-01254
• Device Sequence Number: 10289408
• Product Code: FPP
• UDI-Device Identifier: 00817617029887
• UDI-Public: 00817617029887
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 2
• Summary Report (Y/N): Y
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/07/2026

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
• Device Model Number: 3245-19123
• Device Catalogue Number: 3245-19123
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/30/2026
• Initial Report FDA Received Date: 05/07/2026
• Was Device Evaluated by Manufacturer? (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: Unknown