MAUDE Adverse Event Report: COLOPLAST A/S BROOKS DILATOR; CORPUS CAVERNOSUM DILATOR, REUSABLE

Model Number QB93502400

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Perforation of Vessels (2135)

Event Date 04/28/2023

Event Type  Injury  

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.

Event Description

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.

• Brand Name: BROOKS DILATOR
• Type of Device: CORPUS CAVERNOSUM DILATOR, REUSABLE
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebæk 3050 ; DA 3050
• Manufacturer (Section G): COLOPLAST A/S MANUFACTURING; 9 avenue edmond rostand; sarlat-la-caneda 24206 ; FR 24206
• Manufacturer Contact: usbes brian e schmidt ; 1601 west river road north; minneapolis, MN 55411 ; 8007880293
• MDR Report Key: 16983384
• MDR Text Key: 315747894
• Report Number: 2125050-2023-00609
• Device Sequence Number: 1
• Product Code: KOA
• UDI-Device Identifier: 05708932627320
• UDI-Public: 05708932627320
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/23/2023

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?: Yes
• Device Operator: Health Professional
• Device Model Number: QB93502400
• Device Catalogue Number: QB9350
• Device Lot Number: 8278064
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/28/2023
• Initial Date FDA Received: 05/23/2023
• Date Device Manufactured: 11/16/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 48 YR
• Patient Sex: Male