MAUDE Adverse Event Report: HALYARD HEALTH PURPLE NITRILE* EXAM GLOVE; EXAM GLOVES NITRILE

Model Number 55082

Device Problem Protective Measures Problem (3015)

Patient Problem Burn(s) (1757)

Event Date 02/19/2016

Event Type  Injury  

Manufacturer Narrative

The actual glove involved in the complaint 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.Images provided of the skin graft show that the injury appears to be above the skin area the glove normally covers.Additionally, the glove is not intended to provide a thermal barrier.All information reasonably known as of 02oct2017 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by halyard health represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to halyard health.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 customer was pouring boiling nitric acid into a beaker and without warning a chemical reaction occurred causing acid to spill onto the wrist.The boiling acid burned through the purple nitrile gloves causing third-degree burns, which required a skin graft using skin from the customer¿s right leg.No additional information was provided.

• Type of Device: EXAM GLOVES NITRILE
• Manufacturer (Section D): HALYARD HEALTH; 5405 windward parkway; alpharetta GA 30004
• Manufacturer (Section G): HALYARD HEALTH INC.; 5405 windward parkway; alpharetta GA 30004
• Manufacturer Contact: lisa clark ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485444
• MDR Report Key: 6912413
• MDR Text Key: 88113224
• Report Number: 3011270181-2017-00007
• Device Sequence Number: 1
• Product Code: LZC
• UDI-Device Identifier: 30680651550829
• UDI-Public: 30680651550829
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113423
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 55082
• Device Catalogue Number: 991055082
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/14/2017
• 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