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

Model Number	2881401400
Medical Device Problem Code	Sharp Edges (4013)
Health Effect - Clinical Codes	Pain (1994); Kidney Infection (4502)
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, this complaint describes a harm to a female end-user who have been catheterizing with speedicath compact plus for more than 2 years.The end-user stated that she used two catheters with rough eyelets that scratched her urethra upon entering and withdrawing the catheter.The end-user stated it was painful to use the catheters but confirmed there was no bleeding.The end-user stated that three days after using the rough catheters, she had to go to the emergency room due to a kidney infection.The end-user was hospitalized for four days.She was treated with an 18-day antibiotic infusion treatment.The end-user has since recovered for the kidney infection.It is unclear if the end-user continues to perform intermittent self- catheterization.No further information was provided.
Additional Manufacturer Narrative
2 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 PLUS (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: usgab giovanna abugre ; 1601 west river road north; minneapolis, MN 55411 ; 8007880293
• MDR Report Key: 15299942
• Report Number: 3006606901-2022-00016
• Device Sequence Number: 2407282
• Product Code: GBM
• UDI-Device Identifier: 05708932020633
• UDI-Public: 05708932020633
• 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): 01/13/2023

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 11/04/2023
• Device Model Number: 2881401400
• Device Catalogue Number: 28814
• Device Lot Number: 8293501
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/04/2022
• Supplement Date Received by Manufacturer: 08/04/2022
• Initial Report FDA Received Date: 08/26/2022
• Supplement Report FDA Received Date: 01/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/09/2021
• 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
• Patient Sex: Female