MAUDE Adverse Event Report: MOLNLYCKE HEALTH CARE BIOGEL; GLOVES, SURGICAL, LATEX

Catalog Number 30475

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/12/2018

Event Type  malfunction  

Event Description

When preparing a patient for sterile prep in surgery, the rn opened a pair of sterile gloves.She noticed a black mark on the finger of one glove that appears to be mold.The gloves were within the expiration date.She used stop and resolve and did not use the non-sterile gloves, but instead opened a new pair and prepped the patient with those gloves.

• Brand Name: BIOGEL
• Type of Device: GLOVES, SURGICAL, LATEX
• Manufacturer (Section D): MOLNLYCKE HEALTH CARE; 5550 peachtree parkway; suite 500; norcross GA 30092
• MDR Report Key: 7994461
• MDR Text Key: 124688465
• Report Number: 7994461
• Device Sequence Number: 1
• Product Code: KGO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 10/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 30475
• Device Lot Number: 18E667
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/15/2018
• Event Location: Hospital
• Date Report to Manufacturer: 10/23/2018
• Type of Device Usage: N
• Patient Sequence Number: 1