MAUDE Adverse Event Report: MOLNYCKE HEALTHCARE BIOGEL; SKINSENSE NON-LATEX GLOVE

Model Number 055186403485

Device Problem Device Contamination With Biological Material (2908)

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

Event Date 04/21/2016

Event Type  malfunction  

Event Description

When opening a sealed package of non-latex biogel skin sense sterile gloves found a dead bug on the pinkie of the right glove.

• Brand Name: BIOGEL
• Type of Device: SKINSENSE NON-LATEX GLOVE
• Manufacturer (Section D): MOLNYCKE HEALTHCARE; goteborg ; SW
• MDR Report Key: 5608380
• MDR Text Key: 43767387
• Report Number: MW5061871
• Device Sequence Number: 1
• Product Code: KGO
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 04/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2018
• Device Model Number: 055186403485
• Device Lot Number: 15 K32B
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1