MAUDE Adverse Event Report: HOLLISTER INCORPORATED POUCH, OSTOMY (POUCH, DRAINABLE, PREMIER H#8551) COLLECTOR, OSTOMY

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erythema (1840); Rash (2033); Swelling (2091)

Event Date 09/22/2020

Event Type  Injury  

Event Description

Symptoms: rash, erythema multiform, blister. Suspect drug dosing: use pouch as directed - for ostomy care. Treatment drugs used: adhesive remover (adhesive remover liquid). Diagnosis for use: ostomy supply.

• Brand Name: POUCH, OSTOMY (POUCH, DRAINABLE, PREMIER H#8551)
• Type of Device: COLLECTOR, OSTOMY
• Manufacturer (Section D): HOLLISTER INCORPORATED
• MDR Report Key: 10650111
• Report Number: MW5097147
• Device Sequence Number: 1
• Product Code: EXB
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 10/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information

Was Device Evaluated by Manufacturer?

Is the Device Single Use?

Is This a Reprocessed and Reused Single-Use Device?

Type of Device Usage

• Patient Age: 69 YR