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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC. BULK SURG PAT 3/4 X 3/4 PADDIE, COTTONOID

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CODMAN & SHURTLEFF, INC. BULK SURG PAT 3/4 X 3/4 PADDIE, COTTONOID Back to Search Results
Model Number 24-5405
Device Problem Component Missing (2306)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
The device has been returned for evaluation. Upon completion of the investigation, a follow-up report will be submitted.
 
Event Description
As reported by the distributor, a 10-pack of surgical patties contained nine. The event was not discovered intra-operatively. There were no reports of delay or patient harm.
 
Manufacturer Narrative
The device was returned for evaluation. It was confirmed that there were nine patties rather than 10. A review of the dhr found no discrepancies. Root cause is likely due to operator error. The operator is required to inspect the front and back of the patties and also count the amount of surgical patties. Operators are trained to wrap each string onto a counting card to make it very visible and to confirm that there are only 10 surgical patties on the card. Retraining was initiated to address this issue. Trends will be monitored for this or similar complaints. At present, we consider this complaint to be closed.
 
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Brand NameBULK SURG PAT 3/4 X 3/4
Type of DevicePADDIE, COTTONOID
Manufacturer (Section D)
CODMAN & SHURTLEFF, INC.
325 paramount drive
raynham 02767
Manufacturer (Section G)
CODMAN & SHURTLEFF, INC.
325 paramount drive
raynham 02767
Manufacturer Contact
james kenney
325 paramount drive
raynham, MA 02767
5088282726
MDR Report Key7742670
MDR Text Key115906769
Report Number1226348-2018-10551
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 distributor
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/10/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/02/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number24-5405
Device Catalogue Number24-5405
Device Lot NumberHR3019
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/13/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/20/2018
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 Initial

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