MAUDE Adverse Event Report: NU-HOPE LABORATORIES, INC. TAPE STRIP, REGULAR ADHERING NU-HOPE; TAPE, AND BANDAGE ADHESIVE

Catalog Number 2330

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

Patient Problems Itching Sensation (1943); Rash (2033); Swelling (2091)

Event Date 09/21/2019

Event Type  Injury  

Event Description

Per ed provider note on 09/21/2019: veteran underwent ent surgery (b)(6) 2018 for nasal obstruction w/ deformity with s/p revision nasal septo reconstruction.Veteran has been having puffy eyelids, itchy rash around his mouth, getting worse last night.Denies sob/blurry vision/intense pain.Symptoms: angioedema; skin rash; rash; swelling.

• Brand Name: TAPE STRIP, REGULAR ADHERING NU-HOPE
• Type of Device: TAPE, AND BANDAGE ADHESIVE
• Manufacturer (Section D): NU-HOPE LABORATORIES, INC.
• MDR Report Key: 9516730
• MDR Text Key: 172933792
• Report Number: MW5091880
• Device Sequence Number: 1
• Product Code: KGX
• 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: 11/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: 2330
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/23/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 47 YR