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U.S. Department of Health and Human Services

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

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HALYARD HEALTH POWDERFREE NITRILE TEXTURED GLOVE M 50 EXAM GLOVES NITRILE Back to Search Results
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.
 
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Brand NamePOWDERFREE NITRILE TEXTURED GLOVE M 50
Type of DeviceEXAM 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 Key6298620
MDR Text Key66433184
Report Number3011270181-2017-00001
Device Sequence Number1
Product Code LZC
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
UNKNOWN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
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 Received02/02/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number50602
Device Catalogue Number991050602
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/08/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 02/02/2017 Patient Sequence Number: 1
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