MAUDE Adverse Event Report: COLOPLAST A/S SPEEDICATH COMPACT FEMALE; SPEEDICATH COMPACT CH14 FEMALE

Model Number	2858401400
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Codes	Pain (1994); Tissue Breakdown (2681); Foreign Body In Patient (2687)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Without the benefit of examination and testing, coloplast is precluded from commenting on the condition of the device or the cause of the occurrence.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, this complaint describes an event where the catheter detaches and is stuck inside the end user.In this event, the end user¿s sister/caretaker is aiding the end user in the insertion of the catheter.This event is narrated by the sister.When the catheter detached, the end user was admitted to a walk-in clinic where a health care provider removed the catheter.The end user had undergone some scans, which have revealed a ¿foreign object¿ presumably a broken catheter tip.From the latest information, the end user is still awaiting further scans and surgery date to remove the foreign object.The end user is still catheterizing 4 times per day.The end user experiences abdominal and pelvic pains.However, there has not been any signs of blood or added discomfort when catheterizing.No more information is available at this time.

• Brand Name: SPEEDICATH COMPACT FEMALE
• Common Device Name: SPEEDICATH COMPACT CH14 FEMALE
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebæk 3050 ; DA 3050
• Manufacturer (Section G): COLOPLAST HUNGARY - NYI; coloplast utca 2; nyírbátor 4300 ; HU 4300
• Manufacturer Contact: usmaco maria bosse ; 1601 west river road north; minneapolis, MN 55411 ; 8007880293
• MDR Report Key: 16673787
• Report Number: 3006606901-2023-00007
• Device Sequence Number: 6379529
• Product Code: GBM
• UDI-Device Identifier: 05708932020572
• UDI-Public: 05708932020572
• Combination Product (Y/N): N
• PMA/510(K) Number: K121457
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/04/2023

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: Lay User/Patient
• Device Model Number: 2858401400
• Device Catalogue Number: 28584
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/27/2022
• Initial Report FDA Received Date: 04/04/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 49 YR
• Patient Sex: Female