MAUDE Adverse Event Report: COLOPLAST A/S ELEFANT SUCTION-IRRIGATION DEVICE

Model Number	ASP1851002
Medical Device Problem Codes	Incomplete or Missing Packaging (2312); Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Should additional facts prompt us to alter or supplement any information or conclusions contained in the original mdr or in any prior supplemental reports, a follow-up report will be submitted.
Event or Problem Description
According to the available information, two devices did not have labels.The lot could not be determined because it was unknown which package the devices came from.

• Brand Name: ELEFANT SUCTION-IRRIGATION DEVICE
• Common Device Name: ELEFANT SUCTION-IRRIGATION DEVICE
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebæk 3050 ; DA 3050
• MDR Report Key: 11876633
• Report Number: 9610711-2021-00041
• Device Sequence Number: 4243416
• Product Code: FQH
• UDI-Device Identifier: 03600040274125
• UDI-Public: 03600040274125
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/25/2021

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: Health Professional
• Device Model Number: ASP1851002
• Device Catalogue Number: ASP185
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/27/2021
• Initial Report FDA Received Date: 05/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1