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

Model Number	2870211400
Health Effect - Clinical Codes	Pain (1994); Septic Shock (2068); Chills (2191)
Date of Event	12/08/2017
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 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.Any prior supplemental reports, a follow-up report will be submitted.
Event or Problem Description
According to the available information, the uder inserted the catheter and experienced pain.Blood was noted immediately after.The user took a shower and laid down but began to experience chills.The user then proceeded to the hospital and was treated for septic shock.The patient was hospitalized for 6 days.

• Brand Name: SPEEDICATH COMPACT MALE KIT
• Common Device Name: CATHETER, URETHRAL
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, region hovedstaden 3050 ; DA 3050
• MDR Report Key: 7634811
• Report Number: 3006606901-2018-00016
• Device Sequence Number: 1424621
• Product Code: GBM
• UDI-Device Identifier: 05708932653046
• UDI-Public: 05708932653046
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 06/25/2018

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
• 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: 06/19/2018
• Initial Report FDA Received Date: 06/25/2018
• 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: 44 YR