MAUDE Adverse Event Report: COLOPLAST A/S SPEEDICATH STANDARD (MALE); SPEEDICATH CH14 MALE

Model Number	2841401400
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Hematuria (2558)
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
According to the information provided, the complaint describes harms caused to a (b)(6)-year-old male end-user.The end-user was using speedicath standard catheters from a sample-pack.When catheterising he experienced bleeding, which was severe enough for him to visit the emergency room (er), where he was admitted.The evaluation from the er is stated to be trauma to the prostate when inserting the catheter.The end-user was put on antibiotics, blood thinners and indwelling catheter.It is stated that he we stay on the indwelling catheter until surgery, and hereafter ic might not be necessary for him.The end-user was in hospital from (b)(6) october and was re-admitted the same day due to bleeding starting again.The end-user has a scheduled prostate surgery (b)(6) october after which intermittent catheterization may not be needed.The end-user states that he did not notice any sharp edges or other on the catheter itself.He thinks that it is a use error (maybe he inserted it too forceful).The medical doctor states that he believes that the bleeding was caused by the blood thinner medication.No further information is available.
Additional Manufacturer Narrative
For this case, annex e coding has been changed to l2: e0506 (hemorrhage) and for annex f, ¿additional medical device required¿: f2301 has been added.In section h, "device eval.By manufacturer" has been corrected to "no" device was not returned and annexes b, c, d has been updated to reflect.

• Brand Name: SPEEDICATH STANDARD (MALE)
• Common Device Name: SPEEDICATH CH14 MALE
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebæk 3050 ; DA 3050
• Manufacturer (Section G): COLOPLAST HUNGARY - NYI; coloplast utca 2; nyírbátor 4300 ; HU 4300
• Manufacturer Contact: usmaco maria bosse ; 1601 west river road north; minneapolis, MN 55411 ; 8007880293
• MDR Report Key: 12738984
• Report Number: 3006606901-2021-00029
• Device Sequence Number: 19865415
• Product Code: GBM
• UDI-Device Identifier: 05708932020275
• UDI-Public: 05708932020275
• 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): 01/10/2022

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: 08/17/2023
• Device Model Number: 2841401400
• Device Catalogue Number: 28414
• Device Lot Number: 8162647
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/11/2021
• Supplement Date Received by Manufacturer: 10/11/2021
• Initial Report FDA Received Date: 11/02/2021
• Supplement Report FDA Received Date: 01/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/23/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 64 YR
• Patient Sex: Male