MAUDE Adverse Event Report: CONVATEC DOMINICAN REPUBLIC INC NATURA; POUCH, COLOSTOMY

Model Number 401512

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

Patient Problems Erythema (1840); Itching Sensation (1943); Rash (2033); Skin Irritation (2076); Fungal Infection (2419)

Event Date 02/06/2019

Event Type  Injury  

Manufacturer Narrative

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

It was reported that about 12 months ago, the end user developed a red, itchy rash under the outer edge of the tape collar and on her abdomen where the pouch comfort panel is in contact with her skin.The symptoms started as a moist red rash, then became runny with a strong odor.It eventually dried up and skin became flaky.The cycle then started again.She saw her primary care doctor several months ago, who diagnosed her with a fungal rash and prescribed oral diflucan, and topical nystatin cream.She took several rounds of the diflucan and had been using the nystatin for months with no change in symptoms.She then recently saw a nurse who recommended nystatin powder instead.So, she has been applying the powder topically for the past several weeks.Her skin care routine is to clean with either dial soap, perineal cleanser or plain water, then apply 3 layers of nystatin with a barrier wipe over each layer.She reported that her symptoms have not responded with this treatment either.She then recently tried using dry gauze under the outer edges of the tape collar and under her pouch to keep the pouch material off her skin.She thought her symptoms improved slightly when she used the gauze.No photo is available at this time.

• Brand Name: NATURA
• Type of Device: POUCH, COLOSTOMY
• Manufacturer (Section D): CONVATEC DOMINICAN REPUBLIC INC; km 18.5 parque industrial; itabo, s.a. haina; san cristobal
• Manufacturer (Section G): CONVATEC DOMINICAN REPUBLIC INC; km 18.5 parque industrial; itabo, s.a. haina; san cristobal
• Manufacturer Contact: jeanette johnson ; 7900 triad center drive; suite 400; greensboro, NC 27409 ; 3365424681
• MDR Report Key: 9756038
• MDR Text Key: 183097151
• Report Number: 9618003-2020-03470
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 401512
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/06/2020
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 55