MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; GLOVE,SURG,SENSICARE,ALOE,LF,PF,8

Catalog Number MSG1080

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

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 02/15/2022

Event Type  Injury  

Manufacturer Narrative

The facility reported that they had a student who reported that immediately after donning a pair of gloves, she felt an immediate sensation of intense burning on her hands and ran to the sink to pull the gloves off and run her hand under cold water.The student initially experienced the reaction on their hands and within 3-5 mins their chest and face experienced a reaction as well.The facility reported to the rep that later the same day the student's lips and tongue became swollen and they experienced hives over their entire body.There were no lotions, cleansers or medications used prior to donning the gloves.The student is reportedly allergic to cats, kiwi and pineapple.The student was sent to health services and given oral benadryl 50mg.The next day the student followed up with her primary care doctor who prescribed the client an epipen to keep with her at all times.The student was instructed to only use nitrile gloves until further notice.No additional information is available.A companion sample from the same lot was returned to the manufacturer for evaluation however a definitive root cause was not able to be determined.Due to the reported incident and in an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

Event Description

The facility reported that they had a student experience an allergic reaction after donning a pair of gloves.The student required oral medications and the reaction resolved.

• Type of Device: GLOVE,SURG,SENSICARE,ALOE,LF,PF,8
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: karen trutsch ; three lakes drive; northfield, IL 60093
• MDR Report Key: 13771737
• MDR Text Key: 287249146
• Report Number: 1417592-2022-00038
• Device Sequence Number: 1
• Product Code: KGO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MSG1080
• Device Lot Number: 0063922680-23
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2022
• Date Manufacturer Received: 02/16/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 32 YR
• Patient Sex: Female
• Patient Weight: 74 KG