MAUDE Adverse Event Report: COLOPLAST A/S IMAJIN SILICONE HYDROGEL DOUBLE LOOP URETERAL STENT KIT; UROLOGICAL SURGICAL PROCEDURE KIT, NON-MEDICATED, SINGLE USE

Catalog Number BCHS63

Device Problem Nonstandard Device (1420)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/29/2023

Event Type  malfunction  

Event Description

According to the available information, there was a fragment "of the same" inside the sterile packaging.

Manufacturer Narrative

After receiving this complaint, we searched for other complaints, and we didn¿t find any other complaint on the lot number 9149402.Checking the quality databases revealed no anomaly in connection with the described defect.Unfortunately, no sample is available from the customer.According to our instruction for use (ifu), in the section "warnings and precautions"; it is requested to store the kit in a cool, dry place.The possible consequence is the deterioration of product.B3: estimated date.

• Brand Name: IMAJIN SILICONE HYDROGEL DOUBLE LOOP URETERAL STENT KIT
• Type of Device: UROLOGICAL SURGICAL PROCEDURE KIT, NON-MEDICATED, SINGLE USE
• 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: 18217605
• MDR Text Key: 329134328
• Report Number: 9610711-2023-00252
• Device Sequence Number: 1
• Product Code: FAD
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K180469
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/29/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: BCHS63
• Device Lot Number: 9149402_BCHS631002
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/28/2023
• Supplement Dates Manufacturer Received: 10/14/2015
• Supplement Dates FDA Received: 05/29/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/24/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1