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

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Rash (2033)

Event Date 01/31/2017

Event Type  malfunction  

Manufacturer Narrative

Synergy health north america is unable to confirm if the decontamination gown subject of the reported event, is manufactured or distributed by synergy health north america.Synergy health north america has made multiple attempts to obtain event information from the user facility however, the user facility will not respond.Due to the user facility not responding to synergy health north america¿s follow-up contacts, synergy health north america is unable to determine if the decontamination gown is synergy health north america¿s, if the reported rash occurred due to the gown or if the employee sought or received medical treatment following the reported event.During synergy health north america's initial contact regarding the reported event, the user facility had disposed of the decontamination gown and did not retain surgical convenience kit's label.On february 23, 2017 user facility reported that the end user continued to use the same gown after the initial incident was reported, with no additional or same issues being identified.A follow-up report will be submitted should additional information become available.

Event Description

The user facility reported an employee obtained a rash from wearing a decontamination gown.

• Brand Name: SURGICAL CONVENIENCE KIT
• Type of Device: DECONTAMINATION GOWN
• Manufacturer (Section D): SYNERGY HEALTH NORTH AMERICA; 2595 custer road suite b; salt lake city UT 84104
• Manufacturer (Section G): SYNERGY HEALTH NORTH AMERICA
• Manufacturer Contact: susan vega ; 2595 custer road suite b; salt lake city, UT 84104 ; 8019771100
• MDR Report Key: 6373163
• MDR Text Key: 69265931
• Report Number: 0001722744-2017-00002
• 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: Health Professional
• Type of Report: Initial
• Report Date: 03/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: N/A
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/01/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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