MAUDE Adverse Event Report: MOLNLYCKE BIOGEL PI MICRO; SURGEONS GLOVES

Model Number 48575

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Irritation (1941); Swelling (2091); Patient Problem/Medical Problem (2688)

Event Date 01/16/2019

Event Type  Injury  

Event Description

A hospital staff member experienced an anaphylactic reaction associated with wear of surgical gloves for approximately 10 minutes.They felt unwell within moments of donning the gloves, then experienced generalized skin reaction and severely swollen lips immediately after removal resulting in emergency treatment of antihistamines.No known prior history of skin allergies or hypersensitivity.

• Brand Name: BIOGEL PI MICRO
• Type of Device: SURGEONS GLOVES
• Manufacturer (Section D): MOLNLYCKE; 5550 peachtree parkway; suite 500; norcross GA 30092
• Manufacturer (Section G): MOLNLYCKE HEALTHCARE; 5550 peachtree parkway; 500; norcross GA 30092
• Manufacturer Contact: pat strahl ; 5550 peachtree parkway; suite 500; norcross, GA 30092 ; 4042700985
• MDR Report Key: 8344543
• MDR Text Key: 136303338
• Report Number: 3004763499-2019-00001
• Device Sequence Number: 1
• Product Code: KGO
• Combination Product (y/n): N
• PMA/PMN Number: K141719
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/21/2021
• Device Model Number: 48575
• Device Lot Number: 181192
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/17/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/21/2018
• 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
• Patient Age: 52 YR