MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; GLOVE,SURG, SENSICAREPIMICRO,LF,PF,7

Catalog Number MSG9670Z

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

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 12/10/2021

Event Type  Injury  

Manufacturer Narrative

It was reported that the client placed the gloves on her hands and both hands experienced irritation.The customer reported that she experienced a reaction as soon as the packaging was opened.The end-user has a known allergy to latex, no other allergies to any foods, drugs or environmental allergens.The end-user removed herself from the office area and took an epi pen injection with no additional follow up care required.The end-user is reportedly doing fine.A companion sample was returned for evaluation however 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 any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

Event Description

It was reported that the client placed the gloves on the hands and both hands experienced irritation.

• Type of Device: GLOVE,SURG, SENSICAREPIMICRO,LF,PF,7
• 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: 13119724
• MDR Text Key: 284130274
• Report Number: 1417592-2021-00226
• 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: 12/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: MSG9670Z
• Device Lot Number: 1069403470-3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/23/2021
• Date Manufacturer Received: 12/13/2021
• Was Device Evaluated by Manufacturer?: 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: 28 YR
• Patient Sex: Female
• Patient Weight: 50 KG