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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC. SURG PAT XRAY 1/2X2 (200) PADDIE, COTTONOID

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CODMAN & SHURTLEFF, INC. SURG PAT XRAY 1/2X2 (200) PADDIE, COTTONOID Back to Search Results
Catalog Number 80-1406
Device Problem Incorrect Device Or Component Shipped (2962)
Patient Problem No Information (3190)
Event Date 10/30/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4). It has been communicated that the device is not available for evaluation. 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.
 
Event Description
As reported by the ous affilate, a 10 pack of surgical patties contained 11. There were no reports of delay or patient harm. Event occurred intraoperatively;number of patties added to count then ensured the correct amount were present at end of the procedure.
 
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Brand NameSURG PAT XRAY 1/2X2 (200)
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 Key7047216
MDR Text Key93183335
Report Number1226348-2017-10860
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 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 Received11/20/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number80-1406
Device Lot NumberH60175
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 Received10/30/2017
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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