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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNERGY HEALTH NORTH AMERICA SURGICAL CONVENIENCE KIT SURGICAL GOWN

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SYNERGY HEALTH NORTH AMERICA SURGICAL CONVENIENCE KIT SURGICAL GOWN Back to Search Results
Model Number 1003D
Device Problems Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)
Event Date 07/25/2017
Event Type  Malfunction  
Manufacturer Narrative

No delays or cancellations in patient procedure were reported. The user was not wearing the appropriate gown for the procedure when the reported event occurred. The user was wearing a level 2 gown and should have been wearing a level 3 or level 4 gown to provide adequate barrier protection. Synergy health north america account manager will be conducting in-service training with the user facility on the proper usage of the gowns.

 
Event Description

The user facility reported that at the end of a surgical procedure an employee observed a strike-through on their surgical gown.

 
Manufacturer Narrative

Synergy health north america representative conducted customer (wakemed) in-service training on october 06, 2017 and october 09, 2017 on the proper usage of surgical gowns.

 
Event Description

The user facility reported that the end of a surgical procedure an employee observed a strike-through on their surgical gown.

 
Manufacturer Narrative

Synergy health north america representative conducted customer (wakemed) in-service training on october 06, 2017 and october 09, 2017 on the proper usage of surgical gowns.

 
Event Description

The user facility reported that at the end of a surgical procedure an employee observed a strikethrough on their surgical gown.

 
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Brand NameSURGICAL CONVENIENCE KIT
Type of DeviceSURGICAL GOWN
Manufacturer (Section D)
SYNERGY HEALTH NORTH AMERICA
1416 dogwood way
27302
mebane NC 27302
Manufacturer (Section G)
SYNERGY HEALTH NORTH AMERICA
Manufacturer Contact
marinela cebic
1416 dogwood way
mebane, NC 27302
9195638555
MDR Report Key6854630
MDR Text Key85937187
Report Number0001055892-2017-00010
Device Sequence Number1
Product Code LRO
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 11/03/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/11/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL Number1003D
Device Catalogue Number1003D
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/06/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/01/1900
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 09/11/2017 Patient Sequence Number: 1
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