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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC. BULK SURG STRIP 1/4 X 6 PADDIE, COTTONOID

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CODMAN & SHURTLEFF, INC. BULK SURG STRIP 1/4 X 6 PADDIE, COTTONOID Back to Search Results
Catalog Number 24-5431
Device Problem Component Missing (2306)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
Udi -- (b)(4). Complaint sample was not returned to codman; therefore, an evaluation of the device could not be performed. A review of manufacturing records found no discrepancies when the device was released to stock. The cause(s) of the difficulty reported by the customer could not be determined. Complaint will be closed as 'no complaint sample returned to codman for evaluation'. If the complaint sample becomes available, this complaint will be reopened, and the respective evaluation performed. Trends will be monitored for this or similar complaints. At present, we consider this complaint to be closed.
 
Event Description
As reported by the distributor. A codman surgical strips had fewer than expected and there was a missing component. The 10 pk contained 9, with one of the strips having no string. There were no reports of delay or patient harm. No further information is available.
 
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Brand NameBULK SURG STRIP 1/4 X 6
Type of DevicePADDIE, COTTONOID
Manufacturer (Section D)
CODMAN & SHURTLEFF, INC.
325 paramount drive
raynham MA 02767
Manufacturer (Section G)
CODMAN & SHURTLEFF, INC.
325 paramount drive
raynham MA 02767
Manufacturer Contact
karen anigbo
11 cabot boulevard
mansfield, MA 02048
5088282726
MDR Report Key7889659
MDR Text Key120731926
Report Number1226348-2018-10666
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
Report Date 08/30/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/19/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number24-5431
Device Lot NumberHU3685
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/30/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/24/2018
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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