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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYSTOSCOPE FOR CYSTOSCOPY CYSTOSCOPE AND ACCESSORIES, FLEXIBLE / RIGID

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CYSTOSCOPE FOR CYSTOSCOPY CYSTOSCOPE AND ACCESSORIES, FLEXIBLE / RIGID Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Syncope (1610); Unspecified Infection (1930)
Event Date 05/22/2019
Event Type  Injury  
Event Description

Reporter alleges her husband had a cystoscopy. After the procedure on wednesday (b)(6) 2019, he was fine but complained not feeling too good on thursday. On friday, he passed out and the paramedics were called. He was taken to the local hosp and admitted in the icu for 5 days. He had an infection which was bacterial and was placed on different antibiotics. Wife reports she is not too happy her husband was septic after having a cystoscopy and wants the fda to be aware of this incident.

 
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Brand NameCYSTOSCOPE FOR CYSTOSCOPY
Type of DeviceCYSTOSCOPE AND ACCESSORIES, FLEXIBLE / RIGID
MDR Report Key8874403
MDR Text Key153944258
Report NumberMW5088897
Device Sequence Number1
Product Code FAJ
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation PATIENT FAMILY MEMBER OR FRIEND
Type of Report Initial
Report Date 08/07/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/07/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator NO INFORMATION
Was Device Available For Evaluation? No Answer Provided
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer?
Is The Device Single Use?
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient TREATMENT DATA
Date Received: 08/07/2019 Patient Sequence Number: 1
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