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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RAYNHAM SURG PAT XRAY 1X3 -200 SURGICAL PATTIES

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RAYNHAM SURG PAT XRAY 1X3 -200 SURGICAL PATTIES Back to Search Results
Catalog Number 801408
Device Problem Contamination /Decontamination Problem (2895)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/22/2020
Event Type  malfunction  
Manufacturer Narrative
An investigation has been initiated based on the reported information. Upon completion of the investigation, a follow-up report will be submitted.
 
Event Description
A facility reported that hair was found in sterile package. No patient injury reported, and it is unknown if the product problem led to surgical delay.
 
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Brand NameSURG PAT XRAY 1X3 -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 Key10841102
MDR Text Key219198052
Report Number3014334038-2020-00093
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 health professional,user faci
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/22/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/14/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number801408
Device Lot NumberJ6344K
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/24/2020
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/24/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/06/2020
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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