MAUDE Adverse Event Report: HELSINN HEALTHCARE SA GELCLAIR GEL PAP; DRESSING, WOUND AND BURN, HYDROGEL W/ DRUG AND /OR BIOLOGIC GENERAL & PLASTIC SU

Lot Number 355611

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

Patient Problem Death (1802)

Event Type  Death  

Event Description

Pt passed away.Dose or amount: 15 ml millilitre(s), oral - 3 times a day.

• Brand Name: GELCLAIR GEL PAP
• Type of Device: DRESSING, WOUND AND BURN, HYDROGEL W/ DRUG AND /OR BIOLOGIC GENERAL & PLASTIC SU
• Manufacturer (Section D): HELSINN HEALTHCARE SA
• MDR Report Key: 9081826
• MDR Text Key: 159121084
• Report Number: MW5089840
• Device Sequence Number: 1
• Product Code: MGQ
• Combination Product (y/n): Y
• 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: 09/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2019
• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 11/30/2019
• Device Lot Number: 355611
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 31 YR
• Patient Weight: 47