MAUDE Adverse Event Report: MOLNLYCKE HEALTH CARE MEPILEX BORDER; DRESSING, WOUND

Model Number 295388

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Edema (1820); Urticaria (2278)

Event Date 09/10/2018

Event Type  Injury  

Manufacturer Narrative

Actual model # 295210-10.This report was submitted for similar model.

Event Description

A patient experienced generalized urticaria and dysphonia, edema at the level of the neck, difficulty to swallow 30 minutes after use of the dressing.Dressing was removed and urticaria and dysphonia persisted.Event is resolving without sequelae.Several requests have been made for additional information, however no additional information is available at the time of this report.

• Brand Name: MEPILEX BORDER
• Type of Device: DRESSING, WOUND
• Manufacturer (Section D): MOLNLYCKE HEALTH CARE; 5550 peachtree parkway; suite 500; norcross GA 30092
• Manufacturer (Section G): MOLNLYCKE HEALTH CARE; 5550 peachtree parkway; suite 500; norcross GA 30092
• Manufacturer Contact: pat strahl ; 5550 peachtree parkway; suite 500; norcross, GA 30092 ; 4703750171
• MDR Report Key: 8034378
• MDR Text Key: 126012509
• Report Number: 3004763499-2018-00006
• Device Sequence Number: 1
• Product Code: NAC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 10/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 295388
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/05/2018
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other