MAUDE Adverse Event Report: COLOPLAST HUNGARY KFT SPEEDICATH, ACC CH14 MALE; CATHETER, URETHRAL

Model Number	2848411400
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cyst(s) (1800)
Type of Reportable Event	Death
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, the end user developed a cyst on his prostate from catheterizing, which led to sepsis and passed away on tuesday (b)(6) 2017 (we are investigating this date as it conflicts with the date indicated for start of use of the product) at (b)(6) hospital in (b)(6).Device: coloplast lubricated straight 14 fr intermittent catheter - catheter was in a green foil metal package containing liquid.(no product number has been given so we have used 28484 for this complaint).

• Brand Name: SPEEDICATH, ACC CH14 MALE
• Common Device Name: CATHETER, URETHRAL
• Manufacturer (Section D): COLOPLAST HUNGARY KFT; coloplast utca 2; szabolcs-szatmar-bereg; nyirbator, 4300 ; HU 4300
• MDR Report Key: 8957230
• Report Number: 3006606901-2019-00013
• Device Sequence Number: 13975067
• Product Code: GBM
• UDI-Device Identifier: 05708932020350
• UDI-Public: 05708932020350
• Combination Product (Y/N): N
• 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): 09/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 2848411400
• Device Catalogue Number: 2848411400
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/14/2019
• Initial Report FDA Received Date: 09/03/2019
• 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: 81 YR