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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC. SURGICAL PATTIE, 1/2 X 1/2 SURGICAL SPONGE

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CODMAN & SHURTLEFF, INC. SURGICAL PATTIE, 1/2 X 1/2 SURGICAL SPONGE Back to Search Results
Catalog Number 80-1400
Device Problem Use of Device Problem (1670)
Patient Problem No Information (3190)
Event Date 03/30/2017
Event Type  Injury  
Manufacturer Narrative
(b)(4). Upon completion of the investigation a follow up report will be filed.
 
Event Description
Call center transferred a call from dr. Indicating that he left 6 codman patties inside the patient. He cut them in half and left them in the diaphragm. He thought they were like the ethicon pledgit product. He wants to know what material they are made of and if they can be left in the patient. The rep contacted the dr. And provided specific information on pattie material and stated that to his knowledge the patties should not be left in the patient. It is unclear as to where the product was left (diaphram).
 
Manufacturer Narrative
Doctor left 6 codman patties inside the patient. The representative contacted the dr. And provided specific information (response to doctors request) on pattie material and stated that to his knowledge the patties should not be left in the patient. It is unclear as to where the product was left (diaphram). A review of the ifu for this product code indicates that the product should not be left in the patient. This complaint is associated with user unfamiliarity. The product remains implanted in the patient and it does not appear product will be returned to codman. At the present time this complaint is considered closed. No further action is required.
 
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Brand NameSURGICAL PATTIE, 1/2 X 1/2
Type of DeviceSURGICAL SPONGE
Manufacturer (Section D)
CODMAN & SHURTLEFF, INC.
325 paramount drive
raynham MA 02767
Manufacturer Contact
james kenney
325 paramount drive
raynham, MA 02767
5088282726
MDR Report Key6504611
MDR Text Key73217782
Report Number1226348-2017-10271
Device Sequence Number1
Product Code HBA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K880402
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial,Followup
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/19/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number80-1400
Device Lot NumberH17229
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/25/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 04/19/2017 Patient Sequence Number: 1
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