DESCRIBE TRANSPARENT PFD PATCH 5035837

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-01-16 for DESCRIBE TRANSPARENT PFD PATCH 5035837 manufactured by Merz North America, Inc..

MAUDE Entry Details

• Report Number: 3013840437-2020-00008
• MDR Report Key: 9596955
• Report Source: HEALTH PROFESSIONAL
• Date Received: 2020-01-16
• Date of Report: 2020-03-05
• Date of Event: 2019-09-27
• Date Mfgr Received: 2020-02-10
• Device Manufacturer Date: 2018-08-13
• Date Added to Maude: 2020-01-16
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 0
• Initial Report to FDA: 0
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: PRODUCT SAFETY
• Manufacturer Street: 6501 SIX FORKS ROAD
• Manufacturer City: RALEIGH, NC NC 27615
• Manufacturer Country: US
• Manufacturer Postal: 27615
• Manufacturer Phone: 9195828000
• Manufacturer G1: MERZ NORTH AMERICA, INC.
• Manufacturer Street: 13900 W. GRANDVIEW PARKWAY
• Manufacturer City: STURTEVANT, WI WI 53177
• Manufacturer Country: US
• Manufacturer Postal Code: 53177
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: DESCRIBE TRANSPARENT PFD PATCH
• Generic Name: TRANSPARENT PATCH FOR USE IN TREATMENT OF TATTOOS
• Product Code: PKO
• Date Received: 2020-01-16
• Catalog Number: 5035837
• Lot Number: 18H0359
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: DA
• Device Eval'ed by Mfgr: R
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: MERZ NORTH AMERICA, INC.
• Manufacturer Address: 13900 W. GRANDVIEW PARKWAY STURTEVANT WI 53177 US 53177

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2020-01-16