MAUDE Adverse Event Report: SYNERGY HEALTH NORTH AMERICA SURGICAL GOWNS

Model Number 7004

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

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 05/16/2014

Event Type  malfunction  

Event Description

The or tech was wearing a gown at the beginning of a 2 hour case, when her neck and left forearm started itching.She continued wearing gown until the case was completed.Once she degowned, she noticed a rash on both aforementioned areas.The rash and itching persisted until she applied cortisone cream and benadryl.This or tech used the same type of gown for years and did not have any previous allergic reactions.

Manufacturer Narrative

As a result of this incident, the or tech switched to paper gowns.All washing titrations for 6 weeks prior to the incident were checked and were found to be within acceptable and approval limits.Incident related gown was not returned for further eval, and the work order info was not provided, so no further investigation could be conducted.The same or tech also started to develop allergic reactions to other or products.Three months ago the or changed scrub solutions, and the same or tech developed a reaction to the new solution, which resulted in blisters on her hands.More recently, she developed a rash on her mouth due to the new face mask she wore.As a result of this, she had to use the former type of mask.Face mask and scrub solutions are neither manufactured nor distributed by synergy health north america.

• Brand Name: SURGICAL GOWNS
• Manufacturer (Section D): SYNERGY HEALTH NORTH AMERICA; 6675 business pky.,suite a; elkridge MD 21075
• Manufacturer Contact: 6675 business pky.,suite a; elkridge, MD 21075 ; 4103795252
• MDR Report Key: 4001659
• MDR Text Key: 4777492
• Report Number: 1123757-2014-00027
• Device Sequence Number: 1
• Product Code: FYA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 06/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 7004
• Device Catalogue Number: 7004
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/19/2014
• 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): Required Intervention
• Patient Weight: 82