MAUDE Adverse Event Report: MED WAY INC. MEDVANCE SILICONE FOAM, BOARDERED SILICONE FOAM DRESSING; DRESSING, WOUND, OCCLUSIVE

Lot Number 20211125

Device Problem Use of Device Problem (1670)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 04/23/2023

Event Type  Injury  

Event Description

Were hurt or had a bad side effect (including new or worsening symptoms.Hospitalization), - admitted or stayed longer.

• Brand Name: MEDVANCE SILICONE FOAM, BOARDERED SILICONE FOAM DRESSING
• Type of Device: DRESSING, WOUND, OCCLUSIVE
• Manufacturer (Section D): MED WAY INC.; 1650 horizon pkwy ne, suite 450; buford GA 30518
• MDR Report Key: 17070948
• MDR Text Key: 316693879
• Report Number: MW5118177
• Device Sequence Number: 1
• Product Code: NAD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 06/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Lot Number: 20211125
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Disability; Life Threatening
• Patient Age: 95 YR
• Patient Sex: Female
• Patient Weight: 68 KG
• Patient Race: Black Or African American