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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 Device Misassembled During Manufacturing /Shipping (2912)
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 11 patties were counted in packet instead of 10.
 
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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
vivian nelson
325 paramount drive
raynham, MA 02767
6099362319
MDR Report Key9119494
MDR Text Key160150544
Report Number1226348-2019-00433
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,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/18/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/25/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number801407
Device Lot NumberJ24V01
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 Received03/25/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured02/27/2019
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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