MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; GLOVE,SURG,SENSICARE,ALOE,LF,PF,7.5

Catalog Number MSG1075Z

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

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 12/01/2021

Event Type  Injury  

Manufacturer Narrative

It was reported that the customer had a reaction to the gloves, initially, on the hands, palms, and forearms and then all the way down to the legs.The customer stated that this is not the first time that he has used this product, he has used the product over the last two years.Prior to donning the gloves the customer used sterillium which he has done many times before.The customer reported that he uses approximately 20 pairs of gloves per day and each pair of gloves are used for approximately 5 minutes for each procedure.It is unknown how long he had this specific pair of gloves on prior to experiencing the rash, irritation and itching.The customer denies any known allergies to any foods, drugs or environmental allergens.After experiencing the reaction the customer required treatment with a steroid dose pack, claritin and pepcid (dose and specific length of treatment not reported).No additional medical intervention was required.The rash resolved after three weeks.Companion samples were returned and forwarded to the manufacturer for further evaluation.A definitive root cause could not be determined at this time.Due to the reported incident and in an abundance of caution, this medwatch is being filed.If additional relevant information becomes available a supplemental medwatch will be filed.

Event Description

It was reported that the customer had a reaction to the gloves.

• Type of Device: GLOVE,SURG,SENSICARE,ALOE,LF,PF,7.5
• 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: 13430232
• MDR Text Key: 284968279
• Report Number: 1417592-2022-00006
• 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: 02/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MSG1075Z
• Device Lot Number: 1069403175-2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2022
• Date Manufacturer Received: 01/03/2022
• 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: 56 YR
• Patient Sex: Male
• Patient Weight: 88 KG