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

Model Number	2849401400
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
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
This complaint is for an (b)(6) year-old male end-user.The end-user is new to performing intermittent catheterizations (ic).He had used the catheters for several days without problems, but then experienced severe bleeding when catheterizing.The bleeding continued, and he was admitted to the hospital feeling very weak.Since his hemoglobin levels were acceptable, it was evaluated that a blood transfusion was not necessary.The end-user was tested for in infection, but none was found.The bleeding stopped after 24 hours, and the end-user was admitted for one night.Currently the end-user has an indwelling catheter until follow-up with a urologist in a couple of weeks, where it will be evaluated if the end-user can return to ic.No further information was provided.
Additional Manufacturer Narrative
5 closed samples of this lot were returned at production site for testing.All tested samples met the specification.The reviewed production documents did not reveal any norm deviation about this lot that could be related to the subject of this claim.Based on the observation of the returned samples this complaint cannot be verified as the products met the specification, no deviation was found.We continuously monitor the complaint trends and report it to the management.

• 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: usgab giovanna abugre ; 1601 west river road north; minneapolis, MN 55411 ; 8007880293
• MDR Report Key: 12639567
• Report Number: 3006606901-2021-00026
• Device Sequence Number: 3451452
• Product Code: GBM
• UDI-Device Identifier: 05708932020404
• UDI-Public: 05708932020404
• 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): 03/16/2022

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 Model Number: 2849401400
• Device Catalogue Number: 28494
• Device Lot Number: 8110495
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/20/2021
• Supplement Date Received by Manufacturer: 09/20/2021
• Initial Report FDA Received Date: 10/15/2021
• Supplement Report FDA Received Date: 03/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Age: 83 YR
• Patient Sex: Male