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 Hemorrhage/Bleeding (1888); Laceration(s) (1946); Tissue Breakdown (2681)

Event Date 02/01/2023

Event Type  Injury  

Manufacturer Narrative

Name of affiliation: aspirus (b)(6) hospital.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: (b)(4).Manufacturing site: (b)(4).

Event Description

This emdr is being submitted for one wafer from one market unit with unknown lot number.It was reported by a nurse from a hospital to company¿s representative that the moldable wafer caused a large stoma bleed for a male patient.After, using the product he required a blood transfusion of two units.In addition to this, it was also shared that there was a mucocutaneous separation of the stoma creating a small wound.Furthermore, the complainant confirmed that the consumer was using company¿s known wafer and that it was an appropriate size for consumer¿s urostomy stoma size of which was a little over one inch.The consumer had his first stoma bleed on (b)(6) 2023 and was seen in the emergency room (er).Pressure was applied and the bleeding was stopped.He had his second bleed on (b)(6) 2023, and he was again seen in the er, at that time his hemoglobin was low at five.Then, he was given a total of three units of blood and hemoglobin improved to seven.The consumer was being followed at a wound care clinic for a mucocutaneous separation (separation of the stoma from the skin) from the ten - three o'clock position.He was also being followed by a urologist.The complainant did not feel that the product caused the stoma bleed.However, due to the sensitivity of the consumer's stoma and tendency to bleed, he was going to pursue a cut-to-fit (ctf) option.No photo was available at this time.

• 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: 16672769
• MDR Text Key: 312601320
• Report Number: 9618003-2023-00276
• 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: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2023
• 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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/10/2023
• 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 Sex: Male