MAUDE Adverse Event Report: COLOPLAST A/S FOLYSIL SILICONE CATHETER; INDWELLING URETHRAL DRAINAGE BALLOON CATHETER, NON-ANTIMICROBIAL

Catalog Number	AA6120
Medical Device Problem Code	Unintended Deflation (4061)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/20/2023
Type of Reportable Event	Malfunction
Event or Problem Description
According to the available information, on day 1 of the prostatectomy the catheter fell out and it was observed the balloon was deflated.
Event or Problem Description
According to the available information, on day 1 of the prostatectomy the catheter fell out and it was observed the balloon was deflated.
Additional Manufacturer Narrative
After receiving this complaint, we searched for other complaint and we didn't find other complaints on the lot number 9261070.Our subcontractor was informed of this issue and performed a documentary investigation which revealed no anomaly recorded during production, but this issue could be caused by a raw material issue.Similar case study was done based on same item number aa6120, same defect: 6 similar cases were found.

• Brand Name: FOLYSIL SILICONE CATHETER
• Common Device Name: INDWELLING URETHRAL DRAINAGE BALLOON CATHETER, NON-ANTIMICROBIAL
• Manufacturer (Section D): COLOPLAST A/S; 1 holtedam humlebaek, dk 3050; humlebaek 3050 ; DA 3050
• Manufacturer (Section G): CMF-SARLAT; 9 avenue edmond rostand; sarlat-la-caneda ; FR
• Manufacturer Contact: usbes brian schmidt ; 1601 west river road n; minneapolis, MN 55411
• MDR Report Key: 18221461
• Report Number: 9610711-2023-00253
• Device Sequence Number: 5709798
• Product Code: EZL
• UDI-Device Identifier: 03600040127735
• UDI-Public: 3600040127735
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K013174
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: AA6120
• Device Lot Number: 9261070_AA61201002
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/28/2023
• Supplement Report FDA Received Date: 05/21/2024
• Date Device Manufactured: 07/21/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown