MAUDE Adverse Event Report: COLOPLAST A/S 1PC URO MAXI TRAN 10/55MM TERA; UROSTOMY BAG

Model Number 1247401400

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

Patient Problems Swelling (2091); Post Operative Wound Infection (2446)

Event Type  Injury  

Manufacturer Narrative

Without the benefit of examination and testing, coloplast is precluded from commenting on the condition of the device or the cause of the occurrence.Should additional facts prompt us to alter or supplement any information of conclusions contained in the original mdr or in any prior supplemental reports, a follow-up report will be submitted.

Event Description

According to the information received, the user's wife indicated use of the samples caused skin blistering where the adhesive contacted the skin.These skin blisters "popped" and drained into a nearby surgical incision from a recent ostomy surgery.The incision became infected subsequent to the blisters draining into the wound.The user was now under the doctor's care and receiving antibiotics.The exact nature of the infection nor the specific antibiotic was provided.

• Brand Name: 1PC URO MAXI TRAN 10/55MM TERA
• Type of Device: UROSTOMY BAG
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, DK-30 50; DA DK-3050
• Manufacturer (Section G): COLOPLAST A/S; coloplast hungary kft; buzavirag ut 15; tatabanya, hu 2800 ; HU 2800
• Manufacturer Contact: christine buckvold ; 1601 west river road north; minneapolis, MN 55411 ; 6123024982
• MDR Report Key: 5946058
• MDR Text Key: 54555474
• Report Number: 3003814961-2016-00003
• Device Sequence Number: 1
• Product Code: EXB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Type of Report: Initial
• Report Date: 09/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 1247401400
• Device Catalogue Number: 1247401400
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/17/2016
• Initial Date FDA Received: 09/13/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 56 YR