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

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.

• Brand Name: SURGICAL CONVENIENCE KIT
• Type of Device: SURGICAL 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 Key: 6854630
• MDR Text Key: 85937187
• Report Number: 0001055892-2017-00010
• Device Sequence Number: 1
• Product Code: LRO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Nurse
• 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 Received: 09/11/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1003D
• Device Catalogue Number: 1003D
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/06/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/1900
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other