STOMAHESIVE PASTE * 183910

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2000-03-09 for STOMAHESIVE PASTE * 183910 manufactured by Convatec.

Event Text Entries

[176120] Ulceration of the skin was observed following stomahesive paste use, the pt was admitted to the hosp.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1049092-2000-00001
• MDR Report Key: 268495
• Report Source: 05
• Date Received: 2000-03-09
• Date of Report: 2000-03-01
• Date Mfgr Received: 2000-02-10
• Date Added to Maude: 2000-03-14
• 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: 0
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 0
• Manufacturer Contact: ADRIENNE MCNALLY
• Manufacturer Street: 100 HEADQUARTERS PARK DR
• Manufacturer City: SKILLMAN NJ 08558
• Manufacturer Country: US
• Manufacturer Postal: 08558
• Manufacturer Phone: 9089042630
• Manufacturer G1: *
• Manufacturer Street: *
• Manufacturer City: *
• Manufacturer Country: *
• Single Use: 3
• Remedial Action: OT
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: STOMAHESIVE PASTE
• Generic Name: WOUND DRESSING
• Product Code: EZS
• Date Received: 2000-03-09
• Model Number: *
• Catalog Number: 183910
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Eval'ed by Mfgr: R
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 259921
• Manufacturer: CONVATEC
• Manufacturer Address: 100 HEADQUARTERS PARK DR SKILLMAN NJ 08558 US
• Baseline Brand Name: STOMAHESIVE PASTE
• Baseline Generic Name: OSTOMY ACCESSORY
• Baseline Model No: NA
• Baseline Catalog No: 183910
• Baseline ID: NA
• Baseline Device Family: OSTOMY POUCH AND ACCESSORIES
• Baseline Shelf Life Contained: Y
• Baseline Shelf Life [Months]: 60
• Baseline PMA Flag: N
• Baseline 510K PMN: N
• Baseline Preamendment: N
• Baseline Transitional: N
• 510k Exempt: Y

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization	2000-03-09