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

Model Number	2841601400
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Abdominal Pain (1685); Urinary Tract Infection (2120); Hematuria (2558)
Date of Event	07/02/2021
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.Device has not been received for analysis.
Event or Problem Description
The report concerns a (b)(6) year-old male.He had been using intermittent catheters from (b)(6) 2021 because of urinary retention.On the (b)(6) 2021, he was admitted to hospital with bleeding and a urinary tract infection (staph infection) and was treated with antibiotics.He was discharged after 5 days having recovered from the infection and is currently still catheterizing four times a day with a different brand of catheter.No additional information was provided.
Additional Manufacturer Narrative
Section h clinical signs and symptoms code e1002 abdominal pain deleted.E1302 kidney and urinary tract - hematuria added.9 closed samples of this lot arrived at production site for examination.All returned samples met specification.The reviewed production documents did not reveal any nonconformities about this lot that could be related to this event.
Event or Problem Description
Subsequent to the previously filed medwatch report the following information has been updated.Patient age is 63 years.It was also reported the patient experienced sepsis.

• Brand Name: SPEEDICATH STANDARD (MALE)
• Common Device Name: SPEEDICATH STANDARD CH16 MALE
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebæk 3050 ; DA 3050
• MDR Report Key: 12362411
• Report Number: 3006606901-2021-00022
• Device Sequence Number: 3736545
• 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): 11/04/2021

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: 08/18/2022
• Device Model Number: 2841601400
• Device Catalogue Number: 28416
• Device Lot Number: 7615774
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2021
• Initial Date Received by Manufacturer: 07/30/2021
• Supplement Date Received by Manufacturer: 11/02/2021
• Initial Report FDA Received Date: 08/24/2021
• Supplement Report FDA Received Date: 11/04/2021
• 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
• Patient Age: 63 YR