MAUDE Adverse Event Report: MOLNLYCKE HEALTH CARE BIOGEL ECLIPSE SIZE 7.5; SURGEONS GLOVE

Catalog Number 30575

Device Problem Material Integrity Problem (2978)

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

Event Date 11/18/2014

Event Type  Injury  

Event Description

(b)(4).Received notification that a facility "had several occasions where blood seeped inside the glove when used.Sample from lot # available but not gloves it happened with.Rep was notified." manufacturer was unable to obtain lot number or samples from the user facility.

Manufacturer Narrative

Unable to carry out proper investigation due to absence of sample and lot number.

• Brand Name: BIOGEL ECLIPSE SIZE 7.5
• Type of Device: SURGEONS GLOVE
• Manufacturer (Section D): MOLNLYCKE HEALTH CARE; norcross GA
• Manufacturer Contact: jamie bradshaw ; 5550 peachtree parkway; suite 500; norcross, GA 30092 ; 4703750051
• MDR Report Key: 4379896
• MDR Text Key: 5266710
• Report Number: 3004763499-2014-00026
• Device Sequence Number: 1
• Product Code: KGO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K053443
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 12/29/2014

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 Catalogue Number: 30575
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/18/2014
• Initial Date FDA Received: 12/29/2014
• 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
• Patient Sequence Number: 1
• Patient Outcome(s): Other