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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CODMAN SURGICAL PATTIE PATTIE, COTTONOID

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CODMAN SURGICAL PATTIE PATTIE, COTTONOID Back to Search Results
Catalog Number 80-1404
Device Problems Component Missing (2306); Incorrect Device Or Component Shipped (2962)
Patient Problem No Information (3190)
Event Type  malfunction  
Manufacturer Narrative
The product code was previously unknown. Through the investigation of the manufacturing records, we were able to determine the likely product code number. This report has been updated with the updated information.
 
Manufacturer Narrative
Udi: unknown product code; (10)hd2230. It is not clear if the device is available. Without the device, it is not possible for codman to conduct a proper investigation. Since a lot number has been provided, a review of the manufacturing records will be reviewed. We anticipate that the evaluation will reveal that the device conformed to specifications prior to release. If anything otherwise is found, then a follow up report will be filed. If at some point the device does become available, this complaint will be re-opened, evaluated and a follow up report will be filed. Trends will be monitored for this and similar complaints. At the present time, this complaint is considered closed. Device not available.
 
Event Description
As reported by the ous affiliate, during a procedure, 11 patties were found in a codman pattie 10pk. Two of the patties were sewn to one string. Another lot was used to complete the procedure. There were no reports of delay or patient harm.
 
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Brand NameCODMAN SURGICAL PATTIE
Type of DevicePATTIE, COTTONOID
Manufacturer Contact
james kenney
325 paramount drive
raynham, MA 02767
5088282726
MDR Report Key7236072
MDR Text Key192943669
Report Number1226348-2018-10100
Device Sequence Number1
Product Code HBA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
N/A
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,Followup,Followup
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/02/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number80-1404
Device Lot NumberHD2230
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 Received03/01/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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