MAUDE Adverse Event Report: MOLNLYCKE BIOGEL PI ULTRATROUCH; SURGEON GLOVES

Model Number 41165

Device Problem Material Split, Cut or Torn (4008)

Patient Problems No Consequences Or Impact To Patient (2199); Foreign Body In Patient (2687)

Event Date 06/17/2020

Event Type  malfunction  

Event Description

A surgeon who was double-gloved reported that a guide wire ripped a 2-3mm piece of the outer surgical glove during surgery and the missing piece was not located, despite surgical site irrigation and search of the operating room.No patient or user harm reported.Follow up information received 6jul2020 indicated the patient is stable and recovering well.No medical or secondary surgical intervention reported.No additional information is available or expected.

• Brand Name: BIOGEL PI ULTRATROUCH
• Type of Device: SURGEON GLOVES
• Manufacturer (Section D): MOLNLYCKE; 5550 peachtree parkway; suite 500; norcross, ga
• Manufacturer (Section G): MOLNLYCKE; 5550 peachtree parkway; suite 500; norcross, ga
• Manufacturer Contact: pat strahl ; 5550 peachtree parkway; suite 500; norcross, ga ; 3750171
• MDR Report Key: 10292951
• MDR Text Key: 201730295
• Report Number: 3004763499-2020-00001
• Device Sequence Number: 1
• Product Code: KGO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050184
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/28/2022
• Device Model Number: 41165
• Device Lot Number: 20A222
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/17/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/27/2020
• 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: 37 YR
• Patient Weight: 84