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

Catalog Number 30570

Device Problems Material Integrity Problem (2978); Torn Material (3024)

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

Event Date 01/08/2014

Event Type  malfunction  

Event Description

Glove tears.

Manufacturer Narrative

Waiting on investigation results from the manufacturing facility.

• 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 ; 6782507928
• MDR Report Key: 3865419
• MDR Text Key: 4506966
• Report Number: 3004763499-2014-00004
• 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: 02/08/2014

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: 30570
• Device Lot Number: 13E139
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/08/2014
• 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