BROOKS DILATOR
Received May 23, 2023 · Event occurred Apr 28, 2023
Report 2125050-2023-00609 · MDR key 16983384
Device
Generic name
Corpus Cavernosum Dilator, Reusable
Manufacturer
Coloplast A/sModel number
QB93502400Catalog number
QB9350
Lot number
8278064
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
48 YR · Male
- Perforation of Vessels
- Perforation of Vessels
Narrative
Additional Manufacturer Narrative
THE LOT NUMBER WAS REVIEWED FOR COMPLAINT TREND, NONCONFORMING REPORT AND CAPA. DEVICES MET SPECIFICATION PRIOR TO RELEASE AND NO TRENDS WERE NOTED. 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 OR 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 AVAILABLE INFORMATION, THE PATIENT WITH THIS DEVICE EXPERIENCED A URETHRAL PERFORATION. THIS DEVICE WAS USED TO DILATE THE PATIENT FOR ANOTHER DEVICE IMPLANT. ONLY THE RESERVOIR WAS ABLE TO BE IMPLANTED AND THE PROCEDURE WAS ABORTED DUE TO THE PERFORATION. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.