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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RAYNHAM UNKNOWN SURGICAL PATTIE

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RAYNHAM UNKNOWN SURGICAL PATTIE Back to Search Results
Catalog Number XXX-SURGICAL PATTIE
Device Problem Component Missing (2306)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/31/2019
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 when preparing for the surgical procedure before patient entered the operating room, a packet of size 4 patties were opened for the scrub nurse. When being counted only 9 were in the pack. These were discarded and new pack obtained.
 
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Brand NameUNKNOWN SURGICAL PATTIE
Type of DeviceSURGICAL PATTIE
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 Key10276772
MDR Text Key203671275
Report Number1226348-2019-00627
Device Sequence Number1
Product Code HBA
Combination Product (y/n)N
PMA/PMN Number
NI
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 12/05/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/15/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberXXX-SURGICAL PATTIE
Device Lot NumberJ2255H
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 Received02/26/2020
Was Device Evaluated by Manufacturer? No Answer Provided
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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