MAUDE Adverse Event Report: COLOPLAST A/S BIOSOFT DUO DOUBLE LOOP STENT; URETERAL STENT

Model Number BCAJ751002

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

Patient Problem Urticaria (2278)

Event Type  Injury  

Event Description

The patient suffers from a rash/urticaria since (b)(6) 2019.Since then he is wearing a biosoft duo jj stent - currently the 3rd, which is still in situ.He has been diagnosed with a ureteral tumor and had endoscopic surgery in (b)(6) 2019.He had one revision of the tumor site, and when the site was suspicious again end of april, he again was examined with an endoscope on (b)(6) 2020, but this 3rd time showed only an inflammation of the ureteral tissue.As the skin problem occurred in connection with the biosoft duo stent, and he and his wife (a medical professional) are not able to find another reason, they are quite sure that the patient has an allergic problem with the biosoft duo.I had a detailed call with the patient, and i also could not find another possible source.

Manufacturer Narrative

After receiving this complaint, we searched for other complaint and we found another complaint on the lot n° 7206650.The product reference bcaj751002 lot number 7206650 is a kit checking the quality databases revealed no anomaly in connection with the described defect.The product reference bcaj751002 lot number 7206650 was made with components : ycvb7590 jj stent lot number 6863832 and lot number 6816390; yn286790 pusher lot number 6892271.Unfortunately, no sample, no photo, available from the customer, and we cannot go further than the documentary investigation which didn't reveal any anomaly recorded during production.

Event Description

The physician was provided a sample.On 19 june the patient informed me about the result of the lymphocyte transformation test: it showed no sensitization type i with the patient´s blood sample.

• Brand Name: BIOSOFT DUO DOUBLE LOOP STENT
• Type of Device: URETERAL STENT
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1-3; humlebaek, 3050 ; DA 3050
• MDR Report Key: 10145592
• MDR Text Key: 196091072
• Report Number: 9610711-2020-00021
• Device Sequence Number: 1
• Product Code: FAD
• Combination Product (y/n): N
• PMA/PMN Number: K170422
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Type of Report: Initial,Followup
• Report Date: 07/16/2020

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?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/24/2021
• Device Model Number: BCAJ751002
• Device Catalogue Number: BCAJ75
• Device Lot Number: 7206650
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/17/2020
• Initial Date FDA Received: 06/11/2020
• Supplement Dates Manufacturer Received: 05/17/2020
• Supplement Dates FDA Received: 07/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention