MAUDE Adverse Event Report: COLOPLAST A/S SPEEDICATH STANDARD (MALE); SPEEDICATH STANDARD CH12 MALE

Model Number	2841201400
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Sepsis (2067)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is not returning for analysis.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
The report concerns a man.He explained one catheter was not draining properly so he removed it and tried to reinsert with no success.Upon inspection he noticed the eyelets were much smaller compared to others.No pain or bleeding occurred.However, he did experience extreme involuntary chills and had to get an ambulance where he was hospitalized from (b)(6) 2021.Doctors said he went septic and gave him antibiotics intravenously as well as a prescription to take orally at home.At follow-up it is stated that the end-user is now recovering, and he continues to self-catheterize with intermittent catheters.No additional information provided.

• Brand Name: SPEEDICATH STANDARD (MALE)
• Common Device Name: SPEEDICATH STANDARD CH12 MALE
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebæk 3050 ; DA 3050
• MDR Report Key: 11777605
• Report Number: 3006606901-2021-00012
• Device Sequence Number: 3137636
• Product Code: GBM
• UDI-Device Identifier: 05708932020268
• UDI-Public: 05708932020268
• Combination Product (Y/N): N
• PMA/510(K) Number: K180258
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial

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 Model Number: 2841201400
• Device Catalogue Number: 28412
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/09/2021
• Initial Report FDA Received Date: 05/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening