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

Model Number 10-30

Device Problem Insufficient Information (3190)

Patient Problems Abrasion (1689); Edema (1820); Erythema (1840); Skin Irritation (2076)

Event Date 03/23/2014

Event Type  Injury  

Event Description

Received copy of medwatch form from fda on (b)(4) 2014; form was a copy of a user-facility submission regarding an injury from our products, nuprep skin prep gel and ten20 conductive paste.Patient had an eeg in which both of our products were used.The eeg leads remained on the patient overnight.When the leads were removed, the day following the eeg, two (2) pink areas on the skin of the forehead were observed.About an hour later, the pink areas increased in size and intensity, especially the area on the right side, which was edematous and slightly abraded to the center.The areas continued to increase in size and became more irritated over the next hour.Doctors were alerted and the skin team was consulted.

Manufacturer Narrative

Initial reported contacted to ascertain the current status of the patient, such as if the patient ended up suffering permanent scarring or if the patient recovered completely.As of (b)(4) 2014, no reply from the user facility.If we receive any additional information from the user facility, we will submit a follow-up report.We are aware that a very small percentage of the population may react negatively to our products, likely due to hypersensitive skin and/or allergies.It is very rare that permanent scarring results.

• Brand Name: NUPREP SKIN PREP GEL
• Type of Device: NUPREP
• Manufacturer (Section D): D. O. WEAVER AND COMPANY; 565 nucla way, unit b; aurora CO 80011
• Manufacturer (Section G): D. O. WEAVER AND COMPANY; 565 nucla way, unit b; aurora CO 80011
• Manufacturer Contact: nicholas lee ; 565 nucla way, unit b; aurora, CO 80011 ; 3033661804
• MDR Report Key: 4115882
• MDR Text Key: 4835014
• Report Number: 1718791-2014-00003
• Device Sequence Number: 1
• Product Code: DRX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K885306
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Medical Technologist
• Device Model Number: 10-30
• Device Catalogue Number: 10-30
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/25/2014
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: EEG LEADS; EKG LEAD; TEN20 CONDUCTIVE PASTE; TRACHEOSTOMY TUBE; BP CUFF; PULSE OXIMETER
• Patient Outcome(s): Other
• Patient Age: 1 YR