SPEEDICATH, ACC CH14 MALE
Received Sep 3, 2019
Report 3006606901-2019-00013 · MDR key 8957230
Device
Generic name
Catheter, Urethral
Manufacturer
Coloplast Hungary KftModel number
2848411400Catalog number
2848411400
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
81 YR
- Cyst(s)
- Cyst(s)
Narrative
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.
Description of Event or Problem
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).