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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: XOMED MFG MYSTIC NEURAY® PACKING NEUROSURGICAL PADDIE

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XOMED MFG MYSTIC NEURAY® PACKING NEUROSURGICAL PADDIE Back to Search Results
Model Number 8004000
Device Problem Material Separation (1562)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/19/2019
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
A health care provider (hcp) reported that on a arthroplasty. A device's patties were coming off of the strings. There was no patient impact. Upon follow up it was confirmed that patties were used on a patient during an arthroplasty. It was during the procedure when the rn identified that the patties were coming off of the strings. Here was no impact to patient or staff because this problem was identified during the procedure. His product was discarded during the case due to it being contaminated with blood.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
The event was reported to medwatch but the report number was unknown. There was no delay in the surgical procedure.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
The remaining patties off of the shelf were pulled.
 
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Brand NameNEURAY® PACKING
Type of DeviceNEUROSURGICAL PADDIE
Manufacturer (Section D)
XOMED MFG MYSTIC
950 flanders rd
mystic CT 06355
Manufacturer (Section G)
XOMED MFG MYSTIC
950 flanders rd
mystic CT 06355
Manufacturer Contact
christy cain
6743 southpoint drive north
jacksonville, FL 32216
9043328353
MDR Report Key9568144
MDR Text Key179259474
Report Number1219071-2020-00001
Device Sequence Number1
Product Code HBA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K923027
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 02/19/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/09/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number8004000
Device Catalogue Number8004000
Device Lot Number00030431
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/04/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured10/01/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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