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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COLOPLAST A/S SPEEDICATH STANDARD (MALE); SPEEDICATH SOFT CH14 TIEMANN
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COLOPLAST A/S SPEEDICATH STANDARD (MALE); SPEEDICATH SOFT CH14 TIEMANN Back to Search Results
Model Number 2849401400
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes Sepsis (2067); 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.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
This case involves a (b)(6) year old male end user who while using the speedicath catheter was diagnosed with a bad urinary tract infection which developed into sepsis requiring hospitalization.The end user is awaiting a possible operation for treatment.No additional information was provided.
 
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Brand Name
SPEEDICATH STANDARD (MALE)
Common Device Name
SPEEDICATH SOFT CH14 TIEMANN
Manufacturer (Section D)
COLOPLAST A/S
holtedam 1
humlebæk 3050
DA  3050
MDR Report Key11870183
Report Number3006606901-2021-00016
Device Sequence Number13683856
Product Code GBM
UDI-Device Identifier05708932020404
UDI-Public05708932020404
Combination Product (Y/N)N
PMA/510(K) Number
K180258
Number of Events Summarized1
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) 05/24/2021
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? No
Operator of Device Lay User/Patient
Device Model Number2849401400
Device Catalogue Number28494
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 04/26/2021
Initial Report FDA Received Date05/24/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Hospitalization; Life Threatening;
Patient Age75 YR
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