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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 Known Impact Or Consequence To Patient (2692)
Event Date 09/04/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4). It has been reported that the device will not be returned for evaluation. However, a lot number has been provided. Upon completion of the investigation, a follow-up report will be submitted.
 
Event Description
As reported by the affiliate there was a miscount/component qty shortage of bulk surg pat 1/2 x 1/2 that was discovered prior to the procedure. There was no report of surgical delays or patient harm. The sample is not available.
 
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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 Key7923361
MDR Text Key122216883
Report Number1226348-2018-10686
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 09/10/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/01/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number24-5404
Device Lot NumberHT0097
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 Received10/19/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/27/2018
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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