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

Model Number	404594
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Hypersensitivity/Allergic reaction (1907); Ulcer (2274); Tissue Breakdown (2681); Skin Infection (4544); Skin Inflammation/ Irritation (4545)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The event is considered misuse for clinical misindication.The end user had a developed sensitivity to wafer.Based on clinical review of photos, this is not an acute skin issue as it has occurred over 4 months.Information of end-user (name and address) patient name ¿ (b)(6).Patient street address - (b)(6).Patient city ¿ (b)(6).Patient state ¿ (b)(6).Patient postal code - (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.Fda registration number reporting site: (b)(4).Manufacturing site: (b)(4).
Event or Problem Description
This emdr is being submitted for an unknown number of wafers from three market units of ten wafers.The products were previously ordered from medical equipment company.The consumer's son reported that end user was in the emergency room per pcp (primary care physician) advisement.He reported parastomal skin infection on the affected area below the stoma.This event was started a couple of months ago and was following up with pcp.The issue started when retailer changed the end user¿s product.Customer's son suspected that consumer developed sensitivity to wafer.The product had not been adhering well due to the irritation.She was using topical medications mupirocin, an antibiotic ointment, on parastomal skin ordered by doctor of medicine(md) but stated that it also kept the appliance from adhering.He was not sure of the frequency of application of the mupirocin.He reported some bleeding, but it was unable to quantify the blood.Emergency room doctor would admit consumer to hospital for forty-eight hours for infection for intravenous (iv) antibiotics.General surgeon said ct (computed tomography scan) confirmed parastomal intraabdominal infection.He was ordering alternate products (unknown) online now.Call was also arranged with medical equipment company with customer¿s son on the line, but they were closed.On (b)(6) 2022, an outbound call was made to consumer¿s son, and he additionally reported that end user was admitted to hospital and remained there on iv antibiotics.The photographs were received of multiple open sores to peristomal skin.Son confirmed order from medical equipment company for known reference, but no batch number was available as consumer had used all the products.

• Brand Name: NATURA
• Common Device Name: 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: 15344541
• Report Number: 9618003-2022-04853
• Device Sequence Number: 20064067
• Product Code: EXE
• UDI-Device Identifier: 00768455126682
• UDI-Public: 00768455126682
• Combination Product (Y/N): N
• Initial Reporter State: FL
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 404594
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/05/2022
• Initial Report FDA Received Date: 09/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female