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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC. CODMAN SURGICAL PATTIE NEUROSURGICAL PADDIE

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CODMAN & SHURTLEFF, INC. CODMAN SURGICAL PATTIE NEUROSURGICAL PADDIE Back to Search Results
Model Number 80-1404
Device Problem Component Missing (2306)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/23/2019
Event Type  malfunction  
Event Description
Cottonoid missing from the package when performing the initial count. Repeated the count 3 x with same findings 9 out of 10 present in the package. The package was removed from the field. Not harm to the patient.
 
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Brand NameCODMAN SURGICAL PATTIE
Type of DeviceNEUROSURGICAL PADDIE
Manufacturer (Section D)
CODMAN & SHURTLEFF, INC.
325 paramount drive
raynham MA 02767
MDR Report Key9362380
MDR Text Key167616517
Report Number9362380
Device Sequence Number1
Product Code HBA
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 10/30/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/22/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number80-1404
Device Catalogue Number80-1404
Device Lot NumberHJ1925
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA10/30/2019
Event Location Hospital
Date Report to Manufacturer11/22/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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