MAUDE Adverse Event Report: COOK IRELAND LTD RESONANCE STENT SET; FAD STENT, URETERAL

Catalog Number UNKNOWN

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

Patient Problem Foreign Body Reaction (1868)

Event Type  Injury  

Manufacturer Narrative

Although the rms stent did not malfunction, the patient suffered a metal allergic reaction.The stents' removal can be viewed as intervention.Therefore this event meets the fda mdr criteria of a 'serious injury' report.This complaint is related to a resonance metal stent (rpn unknown) of an unknown lot number.The device has not been returned for evaluation therefore a document based investigation has been carried out.The rpn and/or lot # concerned are unknown therefore a limited investigation was possible.As per the complaint description the physician did not recognize the patient had a metal allergy and placed the resonance stent.On observation of the allergic reaction to the stent materials it was removed from the patient and replaced with a plastic stent.The customer complaint was confirmed based on the customers testimony.As per instructions for use ¿warnings¿ section ¿ ¿use of this device should be based on consideration of risk/benefit factors as they apply to your patient.Informed consent should be obtained to maximize patient compliance with follow up procedures.¿ 'individual variations of interaction between stents and the urinary system are unpredictable.¿ complaints of this nature will continue to be monitored for potential emerging trends.Although the rms stent did not malfunction, the patient suffered a metal allergic reaction.The stents' removal can be viewed as intervention.Therefore this event meets the fda mdr criteria of a 'serious injury' report.This complaint is related to a resonance metal stent (rpn unknown) of an unknown lot number.The device has not been returned for evaluation therefore a document based investigation has been carried out.The rpn and/or lot # concerned are unknown therefore a limited investigation was possible.As per the complaint description the physician did not recognize the patient had a metal allergy and placed the resonance stent.On observation of the allergic reaction to the stent materials it was removed from the patient and replaced with a plastic stent.The customer complaint was confirmed based on the customers testimony.As per instructions for use ¿warnings¿ section ¿ ¿use of this device should be based on consideration of risk/benefit factors as they apply to your patient.Informed consent should be obtained to maximize patient compliance with follow up procedures.¿ 'individual variations of interaction between stents and the urinary system are unpredictable.¿ complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

Since the physician did not recognize the patient has metal allergy, he placed resonance stent.However, allergic reaction was observed.So, the stent was removed from the patient's body, and plastic stent was placed instead.No adverse effect to the patient.Additional information was provided form the sales rep after the interview to the physician.There was no information that the patient has a metal allergy when the physician placed the device into the patient.(one of the family member of the patient has metal allergy.) the physician commented that the relation between the allergy symptom and resonance stent is unknown.

• Brand Name: RESONANCE STENT SET
• Type of Device: FAD STENT, URETERAL
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick ; EI
• Manufacturer Contact: sinead quaid ; o'halloran road; national technology park; limerick ; EI ; 061334440
• MDR Report Key: 5099658
• MDR Text Key: 26594588
• Report Number: 3001845648-2015-00180
• Device Sequence Number: 1
• Product Code: FAD
• Combination Product (y/n): N
• PMA/PMN Number: K063742
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Report Date: 08/28/2015

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 Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/24/2015
• 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: Initial
• Patient Sequence Number: 1