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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RAYNHAM BULK SURG STRIP 1/2 X 6 OEM PATTIES & STRIPS

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RAYNHAM BULK SURG STRIP 1/2 X 6 OEM PATTIES & STRIPS Back to Search Results
Catalog Number 245432
Device Problem Component Missing (2306)
Patient Problem No Consequences Or Impact To Patient (2199)
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 tone of the cottonoids is not on a string.
 
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Brand NameBULK SURG STRIP 1/2 X 6
Type of DeviceOEM PATTIES & STRIPS
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 Key8491492
MDR Text Key141216879
Report Number1226348-2019-00058
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 distributor
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/02/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/08/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number245432
Device Lot NumberHZ5004
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/08/2019
Was Device Evaluated by Manufacturer? Yes
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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