MAUDE Adverse Event Report: CONVATEC DOMINICAN REPUBLIC INC L3O0200 - NATURA; PROTECTOR, OSTOMY

Model Number	413419
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cellulitis (1768); Erythema (1840); Hemorrhage/Blood Loss/Bleeding (1888); Itching Sensation (1943); Tissue Breakdown (2681); Skin Inflammation/ Irritation (4545)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.(b)(4).
Event or Problem Description
The consumer reported to specialist on 31st march 2022 that he experienced skin irritation around tape area after using wafer.Outbound call was made, however, no other information was received.On (b)(6) 2022, consumer called back and reported that he started to have redness on the skin with skin breakdown and bleeding under the tape collar approximately two weeks ago.The redness was only in one area under the tape collar on the side under the stoma.He also had sensations of itching.He went to see his doctor of medicine (md) who felt that he had developed cellulitis under the tape collar and prescribed oral antibiotics.He did not know about antibiotic prescribed by doctor.He also prescribed neosporin to be applied to the area with each wafer change.He completed the course of antibiotics several days ago.The consumer had been using this wafer for at least six months without any difficulties with a wear time of seven days.He reported a skin care routine of using baby shampoo in the shower to clean the peristomal skin.He also uses adhesive remover wipes and skin protectant wipes.The customer was advised to notify his md about the skin condition that had not improved and he continued to have areas of bleeding without blister formation.He denied any evidence of leakage of urine under the wafer.No photo is available at this time.
Additional Manufacturer Narrative
Batch record review: lot 1f04731 was manufactured 07/nov/2021, in the ats #2 manufacturing line with a total of (b)(4) mkus.A batch record review was performed on 28/jul/2022, to verify if all the applicable procedures were followed and no issues were found, all the components for assembly were correct per bom and all the tooling information documented was also correct, sap material id (b)(4) and manufacturing order (b)(4).No discrepancies related to the issue reported were found.Complaint data analysis: on 08/26/2022, a search of complaints into trackwise system for lot number 1f04731 was performed.As a result, a total of 01 complaint was found and 01 is related to the same malfunction code of this investigation.Returned sample evaluation: no photographs associated with this case were received and no unused return sample was expected.Conclusion summary of the related event: based on the preliminary investigation performed, no issues related to the customer experience were found in the batch record review.No significant changes have been made in the process or in the product components that could cause the adverse effects reported by the customer.The product was used in their shelf life.No photos or samples were received and per customer description there is not enough information about how the product was used that leads us to a conclusion, therefore, there is not product malfunction confirmed.Should additional information become available, a follow up report will be submitted.Fda registration number: reporting site: 1049092.Manufacturing site: 9618003.
Event or Problem Description
To date no additional patient or event details have been received.

• Brand Name: L3O0200 - 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: 14191882
• Report Number: 9618003-2022-00472
• Device Sequence Number: 4406841
• Product Code: EXE
• UDI-Device Identifier: 00768455124015
• UDI-Public: 00768455124015
• 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: Consumer,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/31/2022

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 Expiration Date: 06/10/2026
• Device Model Number: 413419
• Device Lot Number: 1F04731
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/31/2022
• Supplement Date Received by Manufacturer: 08/28/2022
• Initial Report FDA Received Date: 04/25/2022
• Supplement Report FDA Received Date: 08/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/11/2021
• 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: Male