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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC. CODMAN SURGICAL PATTIE STERILE X-RAY DETECTABLE PATTIE, COTTONOID

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CODMAN & SHURTLEFF, INC. CODMAN SURGICAL PATTIE STERILE X-RAY DETECTABLE PATTIE, COTTONOID Back to Search Results
Catalog Number 80-1402
Device Problems Component Missing (2306); Device Misassembled During Manufacturing /Shipping (2912)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/16/2019
Event Type  malfunction  
Manufacturer Narrative
Udi: (b)(4). Complaint sample was not returned to codman; therefore, an evaluation of the device could not be performed. A review of manufacturing records found no discrepancies when the device was released. The cause(s) of the difficulty reported by the customer could not be determined. If the complaint sample becomes available, this complaint will be reopened, and the respective evaluation performed. Trends will be monitored for this or similar complaints. At present, we consider this complaint to be closed.
 
Event Description
It was reported that when the surgical pattie product packaging was opened prior to a case starting, there were 11 patties instead of 10. The extra pattie also did not have a thread attached to it. There was no delay in the procedure,the patient was not affected and the situation was remedied by opening another pack from a different batch.
 
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Brand NameCODMAN SURGICAL PATTIE STERILE X-RAY DETECTABLE
Type of DevicePATTIE, 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 Key8309802
MDR Text Key137559449
Report Number1226348-2019-10076
Device Sequence Number1
Product Code HBA
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K880402
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation
Type of Report Initial
Report Date 01/17/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/06/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number80-1402
Device Lot NumberHZ1253
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/17/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/17/2018
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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