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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AMERICAN CONTRACT SYSTEMS, INC. ACS GENERAL SURGERY TRAY

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AMERICAN CONTRACT SYSTEMS, INC. ACS GENERAL SURGERY TRAY Back to Search Results
Model Number CDEX31D
Device Problem Delivered as Unsterile Product (1421)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/10/2019
Event Type  Malfunction  
Event Description

Sterility issue: during case set up the sterile extremity pack was opened. The clear cover was torn open at which point a hair was seen on the inside of the clear package on the outside of the blue table cover. Pack removed from use and new pack used.

 
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Brand NameACS
Type of DeviceGENERAL SURGERY TRAY
Manufacturer (Section D)
AMERICAN CONTRACT SYSTEMS, INC.
904 bethel circle
waunakee WI 53597
MDR Report Key8577286
MDR Text Key143976535
Report Number8577286
Device Sequence Number1
Product Code LRO
Combination Product (Y/N)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 04/17/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/03/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberCDEX31D
Device LOT Number944191
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/17/2019
Event Location Hospital
Date Report TO Manufacturer05/03/2019
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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