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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC. CODMAN SURGICAL PATTIE PADDIE, COTTONOID

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CODMAN & SHURTLEFF, INC. CODMAN SURGICAL PATTIE PADDIE, COTTONOID Back to Search Results
Catalog Number 80-1404
Device Problems Material Discolored (1170); Component Missing (2306); Incorrect Device Or Component Shipped (2962)
Patient Problem No Information (3190)
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Upon completion of the investigation it was noted that the sample was received and reviewed. No sign of burn, mark, or stain. The reported " a surgical pattie was found to have a discolored stain" could not be verified. However; samples were observed to contain 11 patties instead of 10. The 11th pattie was missing string. The dhr/manufacturing lot traveler was pulled and reviewed for lot h27272. All information on the traveler indicates that the product was produced within specifications. There were no engineering change orders or anything unusual relative to the manufacturing documentation of this lot. Therefore, root cause could not be determined. No corrective action will be taken at this time. 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.
 
Event Description
As reported by the ous affiliate, a surgical pattie was found to have a discolored stain / mark on it. Was not discovered during surgery, no patient was involved.
 
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Brand NameCODMAN SURGICAL PATTIE
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 Key7004580
MDR Text Key92112167
Report Number1226348-2017-10808
Device Sequence Number1
Product Code HBA
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K880402
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Initial
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/06/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number80-1404
Device Lot NumberH27272
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/01/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/11/2017
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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