MAUDE Adverse Event Report: COLOPLAST A/S PLATE 2PC Ø100/30-50 W/E TERA; OSTOMY BAG

Model Number 1425401004

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

Patient Problems Erythema (1840); Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943); Rash (2033); Skin Inflammation (2443)

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

(b)(6) 2016: the end user claims about a skin reaction with itching, redness and weeping blisters since 4 weeks.There are 4 areas of different sizes on her skin.The largest size is about an 2-euro-coin.She uses brava powder but the skin condition hasn't improved yet.She consulted a doctor who said that he would need the ingredients of the base plate about making an allergy test but she isn't sure yet if she will make an allergy test or not.(b)(6) 2016: the skin under the base plate hasn't healed yet.She visited the gastroenterologist on (b)(6) 2016 who advised her not to take the medicament remicade for two weeks.Then they will see if the medicament has caused the skin irritation.(b)(6) 2016: the end user has told us that the skin looks much better now.The area that was most affected by the rash isn't reddened anymore.She got antibiotics and now she takes the medicament remicade again.Her outcome is good.

• Brand Name: PLATE 2PC Ø100/30-50 W/E TERA
• Type of Device: OSTOMY BAG
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, da 3050 ; DA 3050
• Manufacturer (Section G): COLOPLAST A/S TATABANYA,; tatabanya, bùzavirág u. 15; 2800 ; HU 2800
• Manufacturer Contact: christine buckvold ; 1601 west river road north; minneapolis, MN 55411 ; 6123024982
• MDR Report Key: 5873245
• MDR Text Key: 52062472
• Report Number: 3003814961-2016-00002
• 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: 08/12/2016

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: 1425401004
• Device Catalogue Number: 1425401004
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/22/2016
• Initial Date FDA Received: 08/12/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 35 YR