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

Model Number 2881201400

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Sepsis (2067)

Event Type  Injury  

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 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.

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)
• Type of Device: 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
• MDR Text Key: 295704761
• Report Number: 3006606901-2022-00015
• Device Sequence Number: 1
• Product Code: GBM
• UDI-Device Identifier: 05708932020626
• UDI-Public: 05708932020626
• Combination Product (y/n): N
• PMA/PMN Number: K072808
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 01/17/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/23/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening
• Patient Age: 61 YR
• Patient Sex: Female