MAUDE Adverse Event Report: CONVATEC INC CURE PRODUCTS; CATHETER, STRAIGHT

Model Number	M16
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device 30 of 30.E1: complainant postal code: (b)(6).Based on the available information, this event is deemed to be a reportable malfunction.To date no additional information has been received.Should additional information become available, a follow-up report will be submitted.Fda registration number reporting site: 1049092, manufacturing site: 3005471919.
Event or Problem Description
Retailer reports the end user received a box of m16 catheters that were all open.No additional information provided.No photo provided.

• Brand Name: CURE PRODUCTS
• Common Device Name: CATHETER, STRAIGHT
• Manufacturer (Section D): CONVATEC INC; 211 american avenue; greensboro NC
• Manufacturer (Section G): CONVATEC INC; 211 american avenue; greensboro NC
• Manufacturer Contact: pamela meadows ; 7815 national service road; suite 600; greensboro, NC ; 3365424679
• MDR Report Key: 18144018
• Report Number: 1049092-2023-00320
• Device Sequence Number: 17861246
• Product Code: EZD
• UDI-Device Identifier: 00815947020048
• UDI-Public: 00815947020048
• Combination Product (Y/N): N
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/09/2023

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 Expiration Date: 10/01/2025
• Device Model Number: M16
• Device Lot Number: 201114-3
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/09/2023
• Initial Report FDA Received Date: 11/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/01/2020
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown