MAUDE Adverse Event Report: CONVATEC INC ESTEEM+ FLEX CONVEX; POUCH, COLOSTOMY

Model Number 421622

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

Patient Problems Inflammation (1932); Laceration(s) (1946); Tissue Damage (2104); Ulcer (2274); Blood Loss (2597)

Event Date 03/05/2020

Event Type  Injury  

Manufacturer Narrative

Based on the available information, this event is deemed to be a serious injury.To date no additional information has been received.Should additional information become available, a follow-up report will be submitted.(b)(4).

Event Description

The end user reported that her stoma fluctuates at the proximal end, and it sometimes gets larger than 25mm and as a result, the convex piece of the appliance rubbed her stoma.It resulted in what appeared to be an ulceration and lacerated her stoma measuring 2mm.She stated that this area, which was at 3 o'clock spot on her stoma, did bleed a small amount but resolved after applying pressure for a few seconds.She noted this area within a few hours of application and removed the appliance and went back to her convex 2-piece appliance.After a couple of days, she developed an "exacerbation" of crohn¿s, which manifested 1-2mm ulcerations to the stoma that comes and goes.When she changed the appliance on (b)(6) 2020, seven ulcerations were noted.Reportedly, her stoma was "inflammed" and enlarged in size.Thereafter, she switched to a durahesive product with a larger wafer stoma opening.She is a nurse practitioner and was caring herself for the stoma at home.She denied hernia or bulge.Her doctor did not want to see her due to the covid issues.She was not using any prescription items on her stoma.Her stoma becomes mushroom shaped when it does fluctuate.No photo is available at this time.

Manufacturer Narrative

Correction (g1) - contact office address: dr.(b)(6).Forlife position is as follows: we have the situation that wrong samples were sent to the patient that did not correspond to her stoma size.In convatec's description in tw is already written that the patient should cvt convex 2-piece appliance use again.With v3 a maximum of 25mm can be cut out.That is a fact.That means the patient did not have the right device.In our opinion the nurse gave wrong advice here.So we´ve closed the investigation at our site.Should additional information become available, a follow-up report will be submitted.Fda registration number: reporting site: 1049092; third party manufacturing site (for life): 3003759552.

Event Description

To date no additional patient or event details have been received.

• Brand Name: ESTEEM+ FLEX CONVEX
• Type of Device: POUCH, COLOSTOMY
• Manufacturer (Section D): CONVATEC INC; 211 american avenue; greensboro NC 27409
• MDR Report Key: 10054605
• MDR Text Key: 196981808
• Report Number: 1049092-2020-00126
• Device Sequence Number: 1
• Product Code: EZQ
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup

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 Expiration Date: 01/01/2022
• Device Model Number: 421622
• Device Lot Number: 0000034736
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 05/04/2020
• Initial Date FDA Received: 05/13/2020
• Supplement Dates Manufacturer Received: 05/04/2020
• Supplement Dates FDA Received: 02/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1