MAUDE Adverse Event Report: COLOPLAST A/S SENSURA ACSTD. CONV.L 50 25/33; OSTOMY BAG

Model Number 1131301004

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Skin Irritation (2076); Tissue Damage (2104); Discomfort (2330); 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

According to the available information, the pharmacy has informed us about a consumer who has used the here complained base plate in (b)(6) 2016.He [she] went to a hospital for treatment.The lesion has been already completely healed.The user has used the here complained item together with coloplast paste (2650) since (b)(6) 2016, the plate was changed on every 3-4th day.The user has noticed her skin became macerated after the 5th plate was removed, she continued with this product, but as the skin became worse (signs of inflammation, very sensible around the stoma) she consulted a doctor who did not prescribed any medicine nor salves, but he recommended to change to sensura click base plate.The skin healed very soon since then, no signs of redness/inflammation etc., the skin is well now.*.

• Brand Name: SENSURA ACSTD. CONV.L 50 25/33
• 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; bùzavirág u. 15, 2800; tatabánya,, ; HU
• Manufacturer Contact: christine buckvold ; 1601 west river road north; minneapolis, MN 55411 ; 6123024982
• MDR Report Key: 6089250
• MDR Text Key: 59497817
• Report Number: 3003814961-2016-00005
• 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: foreign,health professional
• Type of Report: Initial
• Report Date: 11/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 1131301004
• Device Catalogue Number: 1131301004
• Device Lot Number: 5281070
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/25/2016
• 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: 79 YR