MAUDE Adverse Event Report: ZIBO HENGCHANG PLASTIC AND RUBBER PRODUCTS CO. LTD CYPRESS TRILON 2000 PF VINYL EXAM GLOVE; VINYL PATIENT EXAM GLOVES

Catalog Number 25-970

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

Patient Problem Anaphylactoid (2218)

Event Date 12/13/2014

Event Type  Injury  

Event Description

On (b)(6) 2014, (b)(6) called from (b)(6) claiming that an individual went into anaphylactic shock after donning the vinyl glove and received 0.3 epipen.The individual went to the er where she also received 50 mgs of benadryl and 2 steroid shots.Ms (b)(6) stated the individual is doing better after 6 days of oral steroids.Further follow up was conducted by qa with ms (b)(6) on (b)(6) 2014, who stated the individual had the vinyl gloves on for 3 seconds, felt a burning sensation, immediately removed the gloves and washed her hands.Ms (b)(6) stated the only known sensitivity the individual has is to latex.The vinyl gloves are not made with natural rubber latex.As of (b)(6) 2015, this is the only complaint registered for this item number and lot number.

• Brand Name: CYPRESS TRILON 2000 PF VINYL EXAM GLOVE
• Type of Device: VINYL PATIENT EXAM GLOVES
• Manufacturer (Section D): ZIBO HENGCHANG PLASTIC AND RUBBER PRODUCTS CO. LTD; zibo city, shangdong ; CH
• Manufacturer (Section G): CYPRESS MEDICAL PRODUCTS LLC; 1202 south route 31; mchenry IL 60050
• Manufacturer Contact: 1202 south route 31; mchenry, IL 60050
• MDR Report Key: 4417989
• MDR Text Key: 5414324
• Report Number: 1451040-2015-00001
• Device Sequence Number: 1
• Product Code: LYZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: Unknown
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/08/2015,12/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 25-970
• Device Lot Number: CHD06-10
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/19/2014
• Device Age: 6 MO
• Event Location: Other
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention