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

Model Number 421040

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

Patient Problems Erythema (1840); Itching Sensation (1943); Urinary Tract Infection (2120)

Event Type  Injury  

Manufacturer Narrative

A2: age at the time of event - 70 years.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.Reporting site: 1049092.Manufacturing site: 9618003.

Event Description

The end user reported that, she has been using company¿s wafer since (b)(6) 2021.She was uncertain if the tape border has contributed but described the redness and itching as a circle under the mass, mirror image.This has been an ongoing issue beginning around thanksgiving 2023 with unknown number of barriers out of unknown number of boxes, unknown lot number.She mentioned that she called her healthcare professional (hcp) in early (b)(6) to discuss, and she was advised to be seen in the emergency room (er).She was admitted for five days for her skin, she was not aware of a diagnosis, she was placed on intravenous (iv) antibiotics and reported she did have a urinary tract infection (uti) at the time.She did not have access to an ostomy nurse while hospitalized.She relays she called her healthcare professional (hcp) back on monday (b)(6) 2024 with update and due to continued irritation was placed on cephalexin oral 500mg for seven days and fluconazole oral one for seven days.She was to follow up with healthcare professional (hcp) on (b)(6) and plans to obtain referral for local ostomy nurse prior to that time.Her usual wear time with her wafer was seven days.No photo was available, she does not have an email to send photo, but feels her healthcare professional (hcp) may have taken a photo.

• 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: 18674211
• MDR Text Key: 334949376
• Report Number: 9618003-2024-00091
• 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: 01/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 421040
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/17/2024
• 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
• Treatment: ADHESIVE REMOVER.
• Patient Sex: Female