MAUDE Adverse Event Report: MOLNLYCKE HEALTHCARE BIOGEL PI MICRO 8.0; SURGEON'S GLOVE

Model Number 48580

Device Problem Insufficient Information (3190)

Patient Problems Skin Irritation (2076); Patient Problem/Medical Problem (2688)

Event Date 03/14/2016

Event Type  Injury  

Event Description

A doctor reported experiencing dryness and itching of hands as well as shortness of breath when using biogel pi micro gloves.

• Brand Name: BIOGEL PI MICRO 8.0
• Type of Device: SURGEON'S GLOVE
• Manufacturer (Section D): MOLNLYCKE HEALTHCARE; 5550 peachtree parkway; suite 500; lilburn GA 30092
• Manufacturer (Section G): MOLNLYCKE HEALTHCARE; 5550 peachtree parkway; suite 500; norcross GA 30092
• Manufacturer Contact: jamie bradshaw ; 5550 peachtree parkway; suite 500; norcross, GA 30092 ; 4703750051
• MDR Report Key: 5571378
• MDR Text Key: 42491577
• Report Number: 3004763499-2016-00004
• Device Sequence Number: 1
• Product Code: KGO
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K053441
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 03/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 08/01/2018
• Device Model Number: 48580
• Device Lot Number: 15I053
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/14/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/05/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other