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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 Problem Component Missing (2306)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/01/2018
Event Type  malfunction  
Manufacturer Narrative
(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
As reported by the ous affiliate, upon removal from its packaging on the surgical field, surgical patties were lacking the x-ray marker line. 10 pieces out of 10 were normal, but the extra one, which was the 11th piece did not have the x-ray line and strings. It was only a piece of cotton. This incident was found when the staff counted the numbers of the devices. There might have been a possibility of intracorporal residual if they had not known there as the extra piece without any x-ray markers. The extra 11th piece has been already discarded. It was unknown if other packages have the extra pieces. They were used carefully in the surgery which concluded successfully. They were disposed of after the procedure. There were no reports of delay or patient harm. The product will not be returned.
 
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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 Key8300780
MDR Text Key134880659
Report Number1226348-2019-10068
Device Sequence Number1
Product Code HBA
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K880402
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,user facility
Reporter Occupation
Type of Report Initial
Report Date 01/10/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/04/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number80-1402
Device Lot NumberHZ1255
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/10/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/14/2018
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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