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

Model Number 50602

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

Patient Problem Respiratory Distress (2045)

Event Date 01/13/2017

Event Type  Injury  

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 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.

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
• Type of Device: EXAM GLOVES NITRILE
• Manufacturer (Section D): HALYARD HEALTH; 5405 windward parkway; alpharetta GA 30004
• Manufacturer (Section G): SAFESKIN MEDICAL & SCIENTIFIC (THAILAND), LTD.; 200 moo 8 kanchanavanich road; tambol prik; sadao songkhla GA 90120 ; TH 90120
• Manufacturer Contact: lisa clark ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485444
• MDR Report Key: 6298620
• MDR Text Key: 66433184
• Report Number: 3011270181-2017-00001
• Device Sequence Number: 1
• Product Code: LZC
• UDI-Device Identifier: 30680651506024
• UDI-Public: 30680651506024
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Nurse
• Device Model Number: 50602
• Device Catalogue Number: 991050602
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/08/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other