MAUDE Adverse Event Report: MOLNLYCKE BIOGEL SKINSENSE; SURGEON'S GLOVES

Model Number 31465

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

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 06/27/2019

Event Type  Injury  

Event Description

A report was received that an anaphylactic reaction occurred resulting in the wearer reporting to the hospital emergency room for treatment.Follow up information received stated the diagnosis was anaphylactic reaction.Anaphylactic reaction drug protocol was followed.Event resolved several hours later.The wearer is currently taking two prescription allergy medications and keeps an inhaler and epi-pen readily available.Extensive testing with the allergist is scheduled.No results are available at this time.

• Brand Name: BIOGEL SKINSENSE
• Type of Device: SURGEON'S GLOVES
• Manufacturer (Section D): MOLNLYCKE; 5550 peachtree parkway; suite 500; norcross GA 30092
• Manufacturer (Section G): MOLNLYCKE; 5550 peachtree parkway; suite 500; norcross GA 30092
• Manufacturer Contact: pat strahl ; 5550 peachtree parkway; suite 500; norcross, GA 30092 ; 4703750171
• MDR Report Key: 8851171
• MDR Text Key: 152951674
• Report Number: 3004763499-2019-00007
• Device Sequence Number: 1
• Product Code: KGO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K053102
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 31465
• Device Lot Number: (10)18L468
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/02/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/22/2018
• 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): Other