MAUDE Adverse Event Report: HALYARD HEALTH STERLING SG NITRILE SENSI-GUARD POWER-FREE EXAM GLOVES; STERLING NITRILE EXAM GLOVES

Model Number	41660
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Reaction (2414)
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.All information reasonably known as of (b)(6) 2017 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.This product incident is documented in the halyard health complaint database and identified as complaint (b)(4).Device not returned.
Event or Problem Description
It was reported that a customer alleged having an allergic reaction from wearing gloves that involved difficulty breathing, numbness and tingling of the lips.Per the customer the gloves were worn for five minutes prior to having a reaction.Benadryl was taken for the symptoms that lasted for 45 minutes after the gloves were taken off.The customer¿s hands were itchy but no rash, hives or medical intervention reported.The customer is reported to be in stable condition.The customer is allergic to penicillin and fish.No additional information was provided.

• Brand Name: STERLING SG NITRILE SENSI-GUARD POWER-FREE EXAM GLOVES
• Common Device Name: STERLING NITRILE EXAM GLOVES
• Manufacturer (Section D): HALYARD HEALTH; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 6827209
• Report Number: 3011270181-2017-00006
• Device Sequence Number: 19003871
• Product Code: LZA
• UDI-Device Identifier: 30680651416606
• UDI-Public: 30680651416606
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K081089
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 08/03/2017

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: 41660
• Device Catalogue Number: 104166000
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/03/2017
• Initial Report FDA Received Date: 08/29/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 48 YR
• Patient Weight: 86