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

Model Number	2881401400
Medical Device Problem Code	Inadequate or Insufficient Training (1643)
Health Effect - Clinical Codes	Kidney Infection (4502); Localized Skin Lesion (4542)
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the information available, this complaint describes an incident where a female end-user was using a sample of speedicath compact female plus.While catheterizing the end-user experienced bleeding and infection and ended up in hospital having surgery due to the infection.The end-user has fully recovered and is now catheterizing with another coloplast catheter.Not much information is available about the incident, but it seems that the end-user followed the instruction from a health care professional on how to perform catheterization, and this information is stated by the end-user to be ¿poor¿.There is no information on the duration of hospitalizations or the type of surgery nor on the amount of bleeding.No further information was provided.
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.

• 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: 14547552
• Report Number: 3006606901-2022-00013
• Device Sequence Number: 4957074
• 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
• Report Date (Section B): 05/31/2022

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: 2881401400
• Device Catalogue Number: 28814
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/06/2022
• Initial Report FDA Received Date: 05/31/2022
• 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; Hospitalization
• Patient Sex: Female