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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC. BULK SURG PAT 1/2 X 1/2 PADDIE, COTTONOID
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CODMAN & SHURTLEFF, INC. BULK SURG PAT 1/2 X 1/2 PADDIE, COTTONOID Back to Search Results
Catalog Number 24-5404
Device Problem Component Missing (2306)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
(b)(4). It has been reported that the device will not be returned for evaluation. A photo of the device and a lot number has been provided. Upon completion of the investigation, a follow-up report will be submitted.
 
Event Description
As reported by the distributor, a neuro pattie had no string attached. There were no reports of delay or patient harm. Sample is unavailable; photo attached to complaint.
 
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Brand NameBULK SURG PAT 1/2 X 1/2
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
7819715608
MDR Report Key8159867
MDR Text Key131380595
Report Number1226348-2018-10880
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,Followup
Report Date 12/05/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/13/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number24-5404
Device Lot NumberHX7561
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/21/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/28/2018
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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