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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTEGRA NEUROSCIENCES PR BIOPATCH 4150
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INTEGRA NEUROSCIENCES PR BIOPATCH 4150 Back to Search Results
Catalog Number 4150
Device Problem Device Markings/Labelling Problem (2911)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Event Description
It was reported by the operation room staff that the inner packet only has numbers listed without any expiration date or symbols to indicate if it is an expiration date or manufacturing date.The operation room staff states this is confusing as they are removed from the box and placed in the anesthesia cart drawer per hospital process.No other information is available at this time.
 
Manufacturer Narrative
The device involved in the reported incident is not expected to be received for evaluation.An investigation has been initiated based upon the reported information.
 
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Brand Name
BIOPATCH 4150
Type of Device
BIOPATCH
Manufacturer (Section D)
INTEGRA NEUROSCIENCES PR
anasco PR 00610
Manufacturer Contact
rowena bunuan
315 enterprise dr.
plainsboro, NJ 08536
6099362393
MDR Report Key4254485
MDR Text Key21173370
Report Number2648988-2014-00061
Device Sequence Number1
Product Code FRO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K003229
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Distributor
Reporter Occupation Other
Type of Report Initial
Report Date 10/17/2014
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 Number4150
Device Lot Number1124405
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 10/17/2014
Initial Date FDA Received11/13/2014
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 Number1
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