MAUDE Adverse Event Report: MOLNLYCKE HEALTH CARE BIOGEL MICRO SURGICAL GLOVES

Catalog Number 30580

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 12/11/2014

Event Type  malfunction  

Event Description

Operating room personnel report problem has been ongoing over the last 6-8 weeks, sizes 6.5, 7.5 and 8.0 and multiple lot numbers.

Manufacturer Narrative

Water leak was performed on returned and retained samples.Results were within the specification requirements.No defects were found.

• Brand Name: BIOGEL MICRO SURGICAL GLOVES
• Manufacturer (Section D): MOLNLYCKE HEALTH CARE; norcross GA
• Manufacturer Contact: curtis truesdale ; 5550 peachtree parkway; suite 500; norcross, GA 30092 ; 6782557928
• MDR Report Key: 3865424
• MDR Text Key: 4462263
• Report Number: 3004763499-2014-00003
• Device Sequence Number: 1
• Product Code: KGO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K970924
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 30580
• Device Lot Number: 13I152
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/02/2014
• 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
• Type of Device Usage: Unknown
• Patient Sequence Number: 1