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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CODMAN & SHURTLEFF INC. SURG PAT XRAY 1/2X1 -200 SURGICAL PATTIES

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CODMAN & SHURTLEFF INC. SURG PAT XRAY 1/2X1 -200 SURGICAL PATTIES Back to Search Results
Catalog Number 801402
Device Problem Manufacturing, Packaging or Shipping Problem (2975)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/27/2020
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
A facility reported the tantal markings of the patties were not visible under brilliance amplifier. Product was in contact with the patient; however no patient injury reported and the event led to 1 hour surgical delay. The patties were used on an anterior lumbar arthrodesis procedure.
 
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Brand NameSURG PAT XRAY 1/2X1 -200
Type of DeviceSURGICAL PATTIES
Manufacturer (Section D)
CODMAN & SHURTLEFF INC.
325 paramount drive
325 paramount drive
raynham NJ 02767
Manufacturer (Section G)
CODMAN & SHURTLEFF INC.
325 paramount drive
raynham NJ 02767
Manufacturer Contact
vivian nelson
1100 campus drive
princeton, NJ 08540
6099362319
MDR Report Key10399943
MDR Text Key206579685
Report Number3014334038-2020-00020
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 foreign
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 04/08/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/12/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number801402
Device Lot NumberHP1034
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/19/2021
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/19/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/21/2018
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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