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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RAYNHAM SURG PATXRAY 1/2X1/2-200 SURGICAL PATTIES

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RAYNHAM SURG PATXRAY 1/2X1/2-200 SURGICAL PATTIES Back to Search Results
Catalog Number 801400
Device Problem Use of Device Problem (1670)
Patient Problem No Information (3190)
Event Type  malfunction  
Manufacturer Narrative
Attempts are being made to obtain additional information. Upon completion of the investigation, a follow-up report will be submitted.
 
Event Description
It was reported that the patties they have are not visible under fluoro. The patties came as part of this cardinal health surgical pack. They were concerned that there was a patty retained after surgery. They imaged the patient and did not see anything. They then imaged just a patty and did not see anything under fluoro and were concerned. They eventually found the patty and realized it was not retained in the patient.
 
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Brand NameSURG PATXRAY 1/2X1/2-200
Type of DeviceSURGICAL PATTIES
Manufacturer (Section D)
RAYNHAM
325 paramount drive
325 paramount drive
raynham MA 02767
Manufacturer (Section G)
RAYNHAM
325 paramount drive
raynham MA 02767
Manufacturer Contact
kimberly shelly
325 paramount drive
raynham, MA 02767
MDR Report Key8609818
MDR Text Key145113769
Report Number1226348-2019-00145
Device Sequence Number1
Product Code HBA
Combination Product (y/n)N
PMA/PMN Number
K880402
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/10/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/14/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number801400
Device Lot NumberHX1319
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/25/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured06/13/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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