NEW IMAGE FLEXWEAR CUT TO FIT SKIN BARRIER WITHOUT TAPE BORDER 15203

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2019-10-29 for NEW IMAGE FLEXWEAR CUT TO FIT SKIN BARRIER WITHOUT TAPE BORDER 15203 manufactured by Hollister Incorporated.

MAUDE Entry Details

• Report Number: 1119193-2019-00038
• MDR Report Key: 9250813
• Report Source: CONSUMER
• Date Received: 2019-10-29
• Date of Report: 2019-10-29
• Date of Event: 2019-08-24
• Date Mfgr Received: 2019-10-24
• Date Added to Maude: 2019-10-29
• 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: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: LINDA WISOWATY
• Manufacturer Street: 2000 HOLLISTER DRIVE
• Manufacturer City: LIBERTYVILLE IL 600483781
• Manufacturer Country: US
• Manufacturer Postal: 600483781
• Manufacturer Phone: 8473602170
• Manufacturer G1: HOLLISTER INCORPORATED
• Manufacturer Street: 366 DRAFT AVENUE
• Manufacturer City: STUARTS DRAFT VA 244779998
• Manufacturer Country: US
• Manufacturer Postal Code: 244779998
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: NEW IMAGE FLEXWEAR CUT TO FIT SKIN BARRIER WITHOUT TAPE BORDER
• Generic Name: NEW IMAGE FLEXWEAR CUT TO FIT SKIN BARRIER WITHOUT TAPE BORDER
• Product Code: EXB
• Date Received: 2019-10-29
• Model Number: 15203
• Lot Number: UNKNOWN
• Operator: LAY USER/PATIENT
• Device Availability: N
• Device Eval'ed by Mfgr: R
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: HOLLISTER INCORPORATED
• Manufacturer Address: 2000 HOLLISTER DRIVE LIBERTYVILLE IL 600483781 US 600483781

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2019-10-29