MAUDE Adverse Event Report: MOLNLYCKE HEALTH CARE - NORCROSS GA BIOGEL SUPER-SENSITIVE; SURGEONS GLOVE

Catalog Number 82565

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/04/2015

Event Type  Injury  

Event Description

Physician was inserting a chest tube and used his left index finger while placing the chest tube in the patient.Upon removal of his finger, the glove tip of the left index finger was missing.Patient had a thoracoscopy video assisted with removal of foreign body and irrigation of right pleural space.

• Brand Name: BIOGEL SUPER-SENSITIVE
• Type of Device: SURGEONS GLOVE
• Manufacturer (Section D): MOLNLYCKE HEALTH CARE - NORCROSS GA; 5550 peachtree parkway; suite 500; norcross GA 30092
• Manufacturer (Section G): MOLNLYCKE HEALTH CARE - NORCROSS GA; 5550 peachtree parkway; suite 500; norcross GA 30092
• Manufacturer Contact: jamie bradshaw ; 5550 peachtree parkway; suite 500; norcross, GA 30092 ; 4703750051
• MDR Report Key: 5123742
• MDR Text Key: 27340122
• Report Number: 3004763499-2015-00005
• Device Sequence Number: 1
• Product Code: KGO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071700
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Risk Manager
• Report Date: 09/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2017
• Device Catalogue Number: 82565
• Device Lot Number: 14J158
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/02/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other