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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 Incorrect Device Or Component Shipped (2962)
Patient Problem No Information (3190)
Event Date 09/25/2017
Event Type  malfunction  
Manufacturer Narrative
Device was returned for evaluation. A follow up report will be filed upon completion of the investigation.
 
Manufacturer Narrative
Device was returned for evaluation. A follow up report will be filed upon completion of the investigation.
 
Manufacturer Narrative
Upon completion of the investigation it was noted that the product was received and evaluated. The corrective action was to check the manufacturing documentation for this lot and perform a tcr with all the operators associated with this lot under question. The manufacturing documentation was reviewed. Nothing was found to be out of the ordinary with this work order. Root cause is likely due to operator error, this however could not be determined. Per the requirements of the specification the operator is required to count the amount of surgical strips and weigh the package with the strips to verify the count prior to sealing them in the package. A tcr was opened to retrain all the operators that had worked on this product and lot #. Based on the results of this investigation no further action is required. Trends will be monitored for this and similar complaints. At the present time this complaint is closed.
 
Manufacturer Narrative
(b)(4). Upon completion of the investigation a follow up report will be filed.
 
Event Description
As reported by medline, a customer received a pack of surgical strips that had an incorrect amount. The 10 pack contained 12 strips. Event was noted during set up. Replacement product was used to complete procedure. No report of delay or patient harm.
 
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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 Contact
james kenney
325 paramount drive
raynham, MA 02767
5088282726
MDR Report Key6979809
MDR Text Key247570487
Report Number1226348-2017-10791
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,Followup
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/26/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number24-5431
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/20/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/13/2017
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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