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

Model Number 413167

Device Problems Leak/Splash (1354); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hemorrhage/Bleeding (1888); Necrosis (1971); Tissue Breakdown (2681); Contact Dermatitis (4546)

Event Type  malfunction  

Event Description

It was reported that after using the company's known wafer, dermatitis lesions had developed on an old male patient below the barrier just around the circumference of the adhesive material.The end user's soft tissue was distressed and there was total defacellation of peristomal skin in the same way necrosis of the stoma was observed, with loss of epidermis with exposure of dermis which was dark purple in color occurred.It was due to components of the medical device, which was found during the first 24 hours of post-surgery.The patient used the device for less than one day.The device was removed, and it was immediately informed to a specialist surgeon about the issue.Assessment for bleeding stoma was performed and the patient was taken to a surgery for new colostomy remodeling and the skin necrosis was further compromised.Further, institutional wound care professional started enzymatic debridement.For surgical cleaning, chlorhexidine soap and solution was used.During the hospitalization, he had not manifested any allergic event.He had been debriding with company's dressing and had not presented any allergic reaction at that moment.Photographs depicting the issue and patient's progress were received from the complainant.

Manufacturer Narrative

(b)(6).Necrosis was related to the stoma and not related to the barrier as per clinical review of the photos received.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.Fda registration number: reporting site: 1049092.Manufacturing site: 9618003.

Manufacturer Narrative

Additional information received from surgeon added in below fields: b5 describe event of problem:- an additional information was received from the surgeon on (b)(6) 2023 that the barrier was already detached during hospitalization, and it was removed in the operating room for which pulling was never performed and in addition to this it was already detached to a large extent due to the humidity of the stoma and no adhesive release was produced.And she had a necrotic stoma, and she went to surgery twenty-four hours after the first surgery.The surgeon stated that no iodinated solution was removed, currently they used chlorhexidine and saline solution in cleaning protocols for the surgical area.But they stated that at the time the device was installed they did not place any substance.In the operating room area, only the area is dried, and the device is placed directly.The barrier was changed to another company¿s brand, but since autolytic debridement was performed, the affected area was covered with iruxol (collagenase and chloramphenicol) and company¿s sterile hydrocolloid dressing.The patient was on his belly/prone position at all for covid.The barrier had a leak as well.The patient was not wearing an abdominal binder.There was also an update on patient outcome including recent photo that patient who is currently under home care and company supports the head of wound care, healing has been done with company¿s gel in areas of fibrin and slough tissue, company¿s antimicrobial dressing, and hydrocolloid dressing with paste and convex moldable barrier and the treatment is carried out weekly and there are no leaks.The photographs were also received from complainant depicting the issue.B7: other relevant history:- the patient was on hypertensive medications under losartan treatment, but this was suspended in the surgical event.Other comorbidities the patient had high blood pressure controlled for 10 years with first-line drugs.D10 (concomitant medical products and therapy dates).H6: -imdrf med.Dev.Problem codes.Added for barrier leak imdrf health impact.For surgical intervention and additional surgery.To date no additional information has been received.Should additional information become available, a follow-up report will be submitted.Fda registration number: reporting site: 1049092.Manufacturing site: 9618003.

Event Description

To date, additional patient or event details were received which have been added in h10 (addl mfg narrative).

Manufacturer Narrative

Additional information received added in below fields: b5 describe event of problem: - an additional information was received on 02 may 2023 that the patient did not have covid during the time of having surgery or was not lying prone during the first 24 hours of surgery.To date no additional information has been received.Should additional information become available, a follow-up report will be submitted.Fda registration number reporting site: 1049092 manufacturing site: 9618003.

Event Description

To date, additional patient or event details were received which have been added in h10 (addl mfg narrative).

• Brand Name: 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: 16476034
• MDR Text Key: 310590872
• Report Number: 9618003-2023-00238
• Device Sequence Number: 1
• Product Code: EXE
• UDI-Device Identifier: 00768455126439
• UDI-Public: 00768455126439
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 413167
• Device Lot Number: 2A00020
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 10/13/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/04/2022
• 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
• Treatment: CLEANING SOLUTION
• Patient Sex: Male
• Patient Ethnicity: Hispanic