MAUDE Adverse Event Report: COLOPLAST A/S SPEEDICATH COMPACT PLUS (FEMALE); SPEEDICATH COMPACT FEMALE PLUS

Model Number	2881201400
Health Effect - Clinical Code	Sepsis (2067)
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.Once our evaluation is complete, a follow-up report will be submitted.
Event or Problem Description
According to the information available, the end-user was contacted on her 30-day follow up and she reported that, while on a 3-week trip to (b)(6) with her daughter she had been treated for urosepsis and spent 3 days in the hospital.The end-user started experiencing uti symptoms which was occasional pain, burning sensation and cloudy urine when she urinated.She went to a clinic in (b)(6) but was informed it was probably nothing.About 5-6 days after experiencing the symptoms she began to feel incredibly fatigued to the point of almost passing out.She was taken to the emergency room by her daughter where she was treated for urosepsis.The end-user will not use the catheters before seeing her doctor.The end-user had been properly sanitizing her vaginal area before and after catheterization.No malfunction to the catheter was reported.No additional information provided.
Additional Manufacturer Narrative
12 closed samples of this lot were tested.All samples met production requirements.The quality engineer checked the manufacturing process related to the given finished goods lot number and no nonconformities were found that were related to this event.A review of the production documents did not reveal any non-conformity that are related to this event.

• Brand Name: SPEEDICATH COMPACT PLUS (FEMALE)
• Common Device Name: SPEEDICATH COMPACT FEMALE PLUS
• 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: usgab giovanna abugre ; 1601 west river road north; minneapolis, MN 55411 ; 8007880293
• MDR Report Key: 14987499
• Report Number: 3006606901-2022-00015
• Device Sequence Number: 11206963
• Product Code: GBM
• UDI-Device Identifier: 05708932020626
• UDI-Public: 05708932020626
• Combination Product (Y/N): N
• PMA/510(K) Number: K072808
• 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,Followup
• Report Date (Section B): 01/18/2023

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 Expiration Date: 09/19/2023
• Device Model Number: 2881201400
• Device Catalogue Number: 28812
• Device Lot Number: 8208951
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/20/2022
• Supplement Date Received by Manufacturer: 01/17/2023
• Initial Report FDA Received Date: 07/12/2022
• Supplement Report FDA Received Date: 01/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/23/2021
• 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: Hospitalization; Life Threatening
• Patient Age: 61 YR
• Patient Sex: Female