MAUDE Adverse Event Report: COLOPLAST A/S JJ BIOS DUO O/O NDIR GFX CH06; URETERAL STENT

Model Number BNAA631002

Device Problem Insufficient Information (3190)

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Manufacturer Narrative

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 the available information, patient reported high fever episode in the temporal context of the insertion of a ureter stent.Weeping changes had also occurred at the urethral orifice.In the autumn of last year, patients suffered from circulatory problems, shock-like conditions and fever.The stent was removed.Signs of general allergic reaction occurred also in connection with dental work.From the latter, he already identified methacrylate as reason for allergic reaction.The patient received a sample of bcaa94 (lot unknown) from the stock of the hospital where she has been for jj implantation.He chopped parts from the sample and applied extracts with vaseline and water and also a piece of the sample for patch testing.The skin showed no reaction.Due to this, he thinks that the high fever after jj implantation has been caused by an infection.The dermatologist had a hospital report from urology at hand but report did not mention any problems or severe conditions of the patient.Patient is described as an unreliable narrator by md, and the hospital report (urology) would not mention any problems or severe conditions of the patient in connection with the implantation of the jj.

• Brand Name: JJ BIOS DUO O/O NDIR GFX CH06
• Type of Device: URETERAL STENT
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek 3050 ; DA 3050
• Manufacturer (Section G): COLOPLAST A/S MANUFACTURING; 9 avenue edmond rostand; sarlat-la-caneda 24206 ; FR 24206
• Manufacturer Contact: sarah o'gara ; 1601 west rivier road north; minneapolis,, MN 55411 ; 6123578517
• MDR Report Key: 8351426
• MDR Text Key: 136530471
• Report Number: 9610711-2019-00007
• 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,health professional
• Type of Report: Initial
• Report Date: 02/18/2019

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: Health Professional
• Device Model Number: BNAA631002
• Device Catalogue Number: BNAA63
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/22/2019
• Initial Date FDA Received: 02/19/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other