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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); Incorrect Device Or Component Shipped (2962)
Patient Problem No Information (3190)
Event Date 10/23/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4). 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 samples were received and reviewed. Pattie miscount was confirmed. 12 patties present, 2 missing strings. Dhr review conducted and tcr opened for pattie miscount. We will continue to monitor for this or similar complaints for this product code. Samples confirmed and dhr reviewed. No issues present on dhr. Pull tests were all within acceptable range. These patties are produced in a hybrid machine where 10 patties are put in a stack and passed to the operator. The operator manually inspects the patties and wraps the string on the card. During the production, it appears the string was pulled off the 2 patties prior to being stacked. The operator likely noticed 2 strings missing from the card, assumed a miscount, and added 2 patties with strings resulting in 12 patties on the card. Tcr was opened for a miscount as a result of this error. 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 the ous rep, a 10 pack of surgical patties contained 12: 10 with strings and 2 without. There were no reports of delay or patient harm.
 
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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 Contact
james kenney
325 paramount drive
raynham, MA 02767
5088282726
MDR Report Key7026408
MDR Text Key247651087
Report Number1226348-2017-10828
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 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 Received11/13/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number80-1402
Device Lot NumberH82350
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/20/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/28/2017
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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