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U.S. Department of Health and Human Services

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

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CODMAN SHURTLEFF, INC. CODMAN NEUROSURGICAL PADDIE Back to Search Results
Model Number 80-1400
Device Problem Component Missing (2306)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/11/2021
Event Type  malfunction  
Event Description
Mid case during a lumbar laminectomy, scrub noted half a string missing from a codman surgical patty 1/2 inch x 1/2 inch (1. 27cm x 1. 27cm). Scrub immediately notified registered nurse (rn) and surgeon. Extensive search performed by several rns, tech, and surgeon. Codman surgical patty (radiopaque part of cottonoid) was found with partial string attached. No intentional alterations performed to cottonoid. Cottonoid (codman) patty was inside "working tube" while surgeon used burr and kerrisons. No flat plate performed after surgery because radiopaque part of patty (cotton part) was located and the non-radiopaque part (string) was the item missing.
 
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Brand NameCODMAN
Type of DeviceNEUROSURGICAL PADDIE
Manufacturer (Section D)
CODMAN SHURTLEFF, INC.
325 paramount drive
raynham MA 02767
MDR Report Key11514992
MDR Text Key240635046
Report Number11514992
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 03/15/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/18/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number80-1400
Device Catalogue Number801400
Device Lot NumberJ8118Y
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/15/2021
Event Location Hospital
Date Report to Manufacturer03/18/2021
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 Unkown

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