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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: JOHNSON AND JOHNSON INTERNATIONAL ULTRAPRO PLUG SIZE: MEDIUM HERNIA MESH

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JOHNSON AND JOHNSON INTERNATIONAL ULTRAPRO PLUG SIZE: MEDIUM HERNIA MESH Back to Search Results
Model Number UPPM
Device Problem Shelf Life Exceeded (1567)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/05/2016
Event Type  Other  
Event Description

Patient scheduled for an unilateral inguinal hernia repair. Upon completion of the procedure it was discovered by the surgical team that the hernia mesh implanted in the patient expired on (b)(6) 2016. The event was disclosed to the patient by the surgeon and hospital administration. As a follow up to the event, an inventory of all meshes and tissues was performed to ensure there were no other expired items within the department.

 
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Brand NameULTRAPRO PLUG SIZE: MEDIUM HERNIA MESH
Type of DeviceHERNIA MESH
Manufacturer (Section D)
JOHNSON AND JOHNSON INTERNATIONAL
MDR Report Key6208648
MDR Text Key63558016
Report NumberMW5066912
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 12/12/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/27/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date11/30/2016
Device MODEL NumberUPPM
Device LOT NumberHP8CHHBO
Was Device Available For Evaluation? No Answer Provided
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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