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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RAYNHAM SURG PAT XRAY 1/2X3 -200 SURGICAL PATTIES
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RAYNHAM SURG PAT XRAY 1/2X3 -200 SURGICAL PATTIES Back to Search Results
Catalog Number 801407
Device Problem Component Missing (2306)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/11/2019
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 only contains 9 patties and it should contain 10. There were no adverse consequences to the patient or delay. A new package was used.
 
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Brand NameSURG PAT XRAY 1/2X3 -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 Key8460042
MDR Text Key140170936
Report Number1226348-2019-00014
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 user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 03/20/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/28/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number801407
Device Lot NumberHZ12070
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/17/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/23/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/08/2018
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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