MAUDE Adverse Event Report: BOSMA INDUSTRIES FOR THE BLIND, INC. BOSMA ALOE TOUCH ICE; SURGEON'S GLOVE

Model Number 73-20302

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

Patient Problems Erythema (1840); Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943); Rash (2033); Swelling/ Edema (4577)

Event Type  malfunction  

Event Description

Staff reported a skin reaction with rash on hands following 2 minutes of use of gloves.Hands felt itchy, took gloves off, both hands were red and slightly swollen.Fda safety report id# (b)(4).

• Brand Name: BOSMA ALOE TOUCH ICE
• Type of Device: SURGEON'S GLOVE
• Manufacturer (Section D): BOSMA INDUSTRIES FOR THE BLIND, INC. ; indianapolis IN 46278
• MDR Report Key: 12307017
• MDR Text Key: 266210055
• Report Number: MW5103142
• Device Sequence Number: 1
• Product Code: KGO
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 08/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 73-20302
• Device Catalogue Number: 73-20302
• Device Lot Number: AM200706826
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1