MAUDE Adverse Event Report: COLOPLAST A/S SPEEDICATH STANDARD (MALE); SPEEDICATH CH16 MALE

Model Number	2841601400
Medical Device Problem Code	Sharp Edges (4013)
Health Effect - Clinical Code	Urinary Tract Infection (2120)
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
The report concerns a (b)(6) years-old man.He experienced bleeding and pain one day after starting to use samples of speedicath standard male urinary intermittent catheters that he received from his medical doctor.After a visit to his urologist, he was diagnosed with bladder and kidney infection and received antibiotics treatment for the infection.He continued to use the speedicath standard catheters, as he had no others, and his urine was getting darker and darker.He is an experienced user and have performed intermittent catheterization since around year 2000.The end-users stated that the catheters felt like sand-paper upon insertion, the surface felt rough when he touched it with his fingers, but the catheters were wet and there was liquid inside.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 is available.
Additional Manufacturer Narrative
Correction: the device was not returned 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.

• Brand Name: SPEEDICATH STANDARD (MALE)
• Common Device Name: SPEEDICATH CH16 MALE
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebæk 3050 ; DA 3050
• MDR Report Key: 11642461
• Report Number: 3006606901-2021-00009
• Device Sequence Number: 14202886
• Product Code: GBM
• UDI-Device Identifier: 05708932020299
• UDI-Public: 05708932020299
• 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: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/10/2021

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: 11/23/2022
• Device Model Number: 2841601400
• Device Catalogue Number: 28416
• Device Lot Number: 7762903
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/15/2021
• Supplement Date Received by Manufacturer: 08/10/2021
• Initial Report FDA Received Date: 04/09/2021
• Supplement Report FDA Received Date: 08/10/2021
• 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: Other
• Patient Age: 62 YR