MAUDE Adverse Event Report: COLOPLAST A/S SPEEDICATH COMPACT MALE KIT; INTERMITTENT CATHETER

Model Number	2870211400
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Blood Loss (2597)
Date of Event	11/09/2017
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, user experienced heavy bleeding after using the speedicath male compact, to the extent that he went to the emergency room and spent 3 days in the hospital.He initially experienced bleeding on (b)(6) at approximately 9pm.He woke up at 11pm and felt the urge to urinate, which was unusual for him.He then notice a large amount of blood in the urine and went to the emergency room.He spent the next 3 days in the hospital, having lost a significant amount of blood.He is currently on blood thinners.He now has a foley, but hopes to catheterize with a softer product in the future.Eu stated that the catheter actually looked like sharp spears.He said they are like little spears.

• Brand Name: SPEEDICATH COMPACT MALE KIT
• Common Device Name: INTERMITTENT CATHETER
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• MDR Report Key: 7097279
• Report Number: 3006606901-2017-00024
• Device Sequence Number: 1273281
• Product Code: GBM
• UDI-Device Identifier: 05708932653046
• UDI-Public: 05708932653046
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K141382
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 12/06/2017

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: 2870211400
• Device Catalogue Number: 2870211400
• Device Lot Number: 5650207
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2017
• Initial Report FDA Received Date: 12/07/2017
• 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: 85 YR