MAUDE Adverse Event Report: D.O. WEAVER AND COMPANY NUPREP SKIN PREP GEL; ABRASIVE SKIN PREPPING GEL

Model Number 10-30

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Skin Irritation (2076)

Event Date 04/30/2019

Event Type  Injury  

Manufacturer Narrative

Patient was very reluctant to tell us any information about the facility where the incident occurred.She also didn't want to share much about her condition.Patient believes that the injury was a result of the technician scrubbing too hard.Current device labeling informs the user about how much pressure to apply, as well as a clear caution statement to avoid overabrasion.Skin irritation is a known product risk for any topical products, and it is a known fact that some people have sensitive skin that may not react well with certain topical products and/or ingredients of those products.We will submit a follow up report if we receive additional relevant information pertaining to this adverse event.

Event Description

Received a phone call from patient complaining of skin irritation.She stated that she had an echocardiogram and a nuclear stress test, and prior to the testing, the cardiology technician used nuprep skin prep gel to prepare the skin at the electrode sites.Pt stated that she believed the tech scrubbed the skin too hard with the abrasive gel, causing the skin to become irritated.We recommended that she see a dermatologist in order to assess the skin irritation and provide treatment as necessary.According to the pt, the dermatologist said she had "broken capillaries" and prescribed her aczone gel 7.5%, which is typically used to treat acne.

• Brand Name: NUPREP SKIN PREP GEL
• Type of Device: ABRASIVE SKIN PREPPING GEL
• Manufacturer (Section D): D.O. WEAVER AND COMPANY; 565 nucla way, unit b; aurora 80011 9319
• Manufacturer (Section G): D.O. WEAVER AND COMPANY; 565 nucla way, unit b; aurora 80011 9319
• Manufacturer Contact: nicholas lee ; 565 nucla way, unit b; aurora 80011-9319 ; 3033661804
• MDR Report Key: 8679544
• MDR Text Key: 147373643
• Report Number: 1718791-2019-00003
• Device Sequence Number: 1
• Product Code: DRX
• Combination Product (y/n): N
• PMA/PMN Number: K885306
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 10-30
• Device Catalogue Number: 10-30
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/08/2019
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 69 YR