MAUDE Adverse Event Report: HALYARD HEALTH POWDERFREE NITRILE TEXTURED GLOVE M 50; EXAM GLOVES NITRILE

Model Number	50602
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Respiratory Distress (2045)
Date of Event	01/13/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The actual complaint product was not returned for evaluation.A review of the device history record is not possible as no lot number was provided.Root cause could not be determined.Halyard health has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.(b)(4).
Event or Problem Description
It was reported that a patient had an allergic reaction to the nitrile gloves and experienced shortness of breath.Additional information received on 17-jan-2017 that stated, "a nurse used gloves to deliver mitomycin chemo drug to the physician.The nurse only delivered the chemo drug, nothing else.Shortly after putting gloves on the nurse noticed a burning on/around the fingers that quickly spread to the nurses arms in the form of a rash.It was the first time the nurse used these gloves.The nurse was taken to the emergency room with shortness of breath, and was nearly/but not intubated." no additional information was provided.
Additional Manufacturer Narrative
Halyard health has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the halyard health complaint database and identified as (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that a halyard health product is defective or caused serious injury.

• Brand Name: POWDERFREE NITRILE TEXTURED GLOVE M 50
• Common Device Name: EXAM GLOVES NITRILE
• Manufacturer (Section D): HALYARD HEALTH; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 6298620
• Report Number: 3011270181-2017-00001
• Device Sequence Number: 19054029
• Product Code: LZC
• UDI-Device Identifier: 30680651506024
• UDI-Public: 30680651506024
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: UNKNOWN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Nurse
• Device Model Number: 50602
• Device Catalogue Number: 991050602
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/16/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/02/2017
• Supplement Report FDA Received Date: 02/16/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other