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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTEGRA YORK, PA INC PESSARY CUBE WO/DRAIN SZ5 45MM; M7 - OB-GYN

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INTEGRA YORK, PA INC PESSARY CUBE WO/DRAIN SZ5 45MM; M7 - OB-GYN Back to Search Results
Catalog Number 30-CU5
Device Problems Detachment Of Device Component (1104); Component Falling (1105)
Patient Problem Injury (2348)
Event Date 12/15/2014
Event Type  malfunction  
Event Description
Patient initially reported the handle fell off of pessary cube.The patient could not get the cube out and her daughter had to help her remove the cube.On (b)(6) 2015 patient reports that the handle on the pessary broke off as she was attempting to remove it (per instructions to do so every three days) for cleaning.The patient had the device in use for about 4 weeks before the event occurred.No major harm done, slight irritation and brief scant bleeding for less than a day.
 
Manufacturer Narrative
Device is labeled for single person use.To date the device involved in the reported incident has not been received for evaluation.An investigation has been initiated based on the reported information.
 
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Brand Name
PESSARY CUBE WO/DRAIN SZ5 45MM
Type of Device
M7 - OB-GYN
Manufacturer (Section D)
INTEGRA YORK, PA INC
york PA 17402
Manufacturer Contact
sandra lee
315 enterprise drive
6099366828
MDR Report Key4475528
MDR Text Key5562929
Report Number2523190-2015-00003
Device Sequence Number1
Product Code EKS
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 01/08/2015
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 Number30-CU5
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 01/13/2015
Initial Date FDA Received01/28/2015
Was Device Evaluated by Manufacturer? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Age76 YR
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