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

Model Number	2870211400
Health Effect - Clinical Code	Urinary Tract Infection (2120)
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.On (b)(6) 2017: report was delayed due to an esg issue.Tickets (b)(4) were opened on (b)(6) 2017 and not resolved until (b)(6) 2017.
Event or Problem Description
According to the available information, end user has had 4 utis in the last 6 months and trying to figure out why.He is in the hospital right now after running a fever and chills.They are doing a cultural right now.End user went into bathroom to cath.Emptied the residue from his cath and noticed it was yellow and is alarmed.I assured her that i am not worried.She isn't sure if the caths she brought from home are from the same box or a new box that he had been using.The lot# is either 4753627 or 4753827.She is going to start paying attention of how he caths going forward.He uses gloves and he cleans the area thoroughly so she is sure it isn't anything he is doing.It's the speedicath compact where the bag is not attached to the catheter.Additional information received indicates they were at the dr's office.End user was hospitalized with a uti for the third time in 6 months.Each time the uti is a different strain.This time he was hospitalized with a klebsiella.They went back to a closed coloplast catheter.

• Brand Name: SPEEDICATH COMPACT MALE KIT
• Common Device Name: INTERMITTENT CATHETER
• Manufacturer (Section D): COLOPLAST A/S MANUFACTURING FRANCE SAS; 9 avenue edmond rostand; sarlat-la-can?da, 24206 ; FR 24206
• MDR Report Key: 6681597
• Report Number: 3006606901-2017-00015
• Device Sequence Number: 13923836
• Product Code: GBM
• UDI-Device Identifier: 05708932653046
• UDI-Public: 05708932653046
• Combination Product (Y/N): N
• 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): 05/30/2017

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
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/02/2017
• Initial Report FDA Received Date: 06/30/2017
• 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: 33 YR