MAUDE Adverse Event Report: CONVATEC DOMINICAN REPUBLIC INC L3O0675 - ESTEEM+; POUCH, COLOSTOMY

Model Number 413522

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Hemorrhage/Bleeding (1888); Skin Inflammation/ Irritation (4545)

Event Type  Injury  

Manufacturer Narrative

Device 17 of 20.The product malfunction for the reported event is considered as unclear since end user experienced more frequent changes, and it was unclear why the end user was changing so often as per the information provided.Based on the available information, this event is deemed to be a serious injury.This complaint has been evaluated.No lot number is available.A detailed investigation or batch review cannot be conducted.Therefore, this evaluation will be closed.This issue will be monitored through the post market product monitoring review process.To date no additional information has been received.Should additional information become available, a follow-up report will be submitted.Fda registration number (b)(4).

Event Description

The end user reported that most of the appliances were used from twenty appliances out of two boxes of ten appliances each from an unknown lot number.She experienced skin irritation and saw the wound center next day's morning.She also stated that she has raised areas around her stoma which sometimes minimally bleed, and the frequent appliance changes led to bleeding of noted areas.Therefore, consumer was treated with silver nitrate by the wound center.She did not take blood thinners.She discontinued the product and was currently using a two-piece competitor appliance and had previously obtained a three-day wear time.She had an ileostomy in (b)(6) 2021 and has a reversal planned for (b)(6) 2022.No photo is available at this time.

• Brand Name: L3O0675 - ESTEEM+
• Type of Device: POUCH, COLOSTOMY
• Manufacturer (Section D): CONVATEC DOMINICAN REPUBLIC INC; km 18.5 parque industrial; itabo, s.a. haina; san cristobal 91000 ; DR 91000
• Manufacturer (Section G): CONVATEC DOMINICAN REPUBLIC INC; km 18.5 parque industrial; itabo, s.a. haina; san cristobal 91000 ; DR 91000
• Manufacturer Contact: pamela meadows ; 7815 national service road; suite 600; greensboro, NC ; 3365424679
• MDR Report Key: 14249100
• MDR Text Key: 290445659
• Report Number: 9618003-2022-00539
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 413522
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/07/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 53
• Patient Sex: Female