MAUDE Adverse Event Report: COLOPLAST A/S SPEEDICATH CH12 TIEMANN; CATHETER, URETHRAL

Model Number	2849201400
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
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.Should additional facts prompt us to alter or supplement any information of conclusions contained in the original mdr or in any prior supplemental reports, a follow-up report will be submitted.
Event or Problem Description
According to the available information, a (b)(6) years old male.He is a severe diabetic and has had a quadruple heart bypass.In early (b)(6) 2020, he catheterized 4 times with a coloplast sample box of sc tiemann ch12 (item 284920), after which he experienced a urinary tract infection (uti) and kidney infection (which is also a uti).He was admitted to hospital and was treated with antibiotics (no further information available regarding the treatment).He was discharged after 5 days and is no longer catheterizing.The patient has fully recovered from the uti/kidney infection and, according to the information obtained, did not suffer permanent injuries.

• Brand Name: SPEEDICATH CH12 TIEMANN
• Common Device Name: CATHETER, URETHRAL
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, region hovedstaden 3050 ; DA 3050
• MDR Report Key: 9938110
• Report Number: 3006606901-2020-00002
• Device Sequence Number: 19021256
• Product Code: GBM
• UDI-Device Identifier: 05708932020398
• UDI-Public: 05708932020398
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K023254
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/08/2020

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: 2849201400
• Device Catalogue Number: 2849201400
• Device Lot Number: 7095346
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/18/2020
• Initial Report FDA Received Date: 04/08/2020
• 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: 71 YR