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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 Patient Involvement (2645)
Event Date 02/26/2019
Event Type  Malfunction  
Event Description

A hair was found in the cmc extremity pack prior to the patient entering the room. Stated that the hair was found on inside fold area of the pack. The pack was removed from the room. A new one was obtained.

 
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Brand NameACS
Type of DeviceGENERAL SURGERY TRAY
Manufacturer (Section D)
AMERICAN CONTRACT SYSTEMS, INC.
7702 parnell st
houston TX 77021
MDR Report Key8407232
MDR Text Key138398691
Report Number8407232
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 02/28/2019,02/27/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/11/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberCDEX31D
Device LOT Number990191
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/28/2019
Event Location Hospital
Date Report TO Manufacturer03/11/2019
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? No
Type of Device Usage

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