MAUDE Adverse Event Report: CONVATEC DOMINICAN REPUBLIC INC L3O0200 - NATURA; PROTECTOR, OSTOMY

Model Number 404593

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

Patient Problems Ulcer (2274); Pressure Sores (2326); Tissue Breakdown (2681); Skin Inflammation/ Irritation (4545)

Event Type  Injury  

Manufacturer Narrative

(b)(6).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.(b)(4).

Event Description

The end user reported "ulcers" to the peristomal skin at 2 o'clock and 9-10 o'clock that started approximately 3 weeks ago.The 2 o'clock one had healed with crusting and with moving to a non-company soft convex appliance.She stated that initially, it had depth but she was not able to provide measurements.The one at 9-10 o'clock was getting bigger but was less painful and superficial.She was not able to provide the size but stated that it followed the curve of the convexity and flange.She believed them to be pressure injuries caused by the convexity or flange but this had not been diagnosed by a health care provider.She had made an appointment at the wound clinic but could not be seen until (b)(6) 2021.Based on additional information received, the end user was seen by the physician at the wound clinic and was diagnosed with a stage 3 pressure injury.She stated xeroform was recommended over the wound, covered by duoderm extra thin.The wound care was ordered twice daily.She was struggling with doing the care twice daily as she was running out of supplies.She called us back to obtain samples of a soft convex.She advised the wound did not appear to be getting smaller.She had a follow up with the physician in 6 weeks.She was at her wit¿s end because of running out of supplies.She was a long-term user of this product (since her last revision in 2015) and did not normally have any skin concerns.She could not think of anything that precipitated the appearance of these--no change in stoma information, weight or abdominal assessment.She was on a biologic-entyvio, which she stated might have had an impact on healing.She used hibiclens to cleanse the skin, brava no sting powder for crusting and brava no sting spray.She did not recall what accessory products if any were used when this issue occurred except for the wafer and cleansing (hibiclens).The provided photo was taken prior to her initial call but she was unable to provide the exact date.

• Brand Name: L3O0200 - NATURA
• Type of Device: PROTECTOR, OSTOMY
• 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: 12525100
• MDR Text Key: 273088910
• Report Number: 9618003-2021-02432
• Device Sequence Number: 1
• Product Code: EXE
• 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: 08/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 404593
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/31/2021
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 62