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

Model Number 404593

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

Patient Problems Erythema (1840); Fungal Infection (2419); Skin Inflammation/ Irritation (4545)

Event Type  malfunction  

Manufacturer Narrative

Contact office address: (b)(4).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 Description

The end user reported that approximately two weeks ago from the date of this report, he started to develop red skin and irritation under the tape collar below the stoma.He stated that it started out the size of a quarter and had advanced to the size of a silver dollar.The area was red but he denied blister formation.He also stated that the redness extended beyond the tape collar.He was evaluated by a doctor and a dermatologist who felt that he had either a yeast/fungal infection or was having a skin sensitivity reaction.He was prescribed doxycycline pills, ketoconazole and triamcinolone cream.He did not use the creams as he was later evaluated by a nurse who prescribed nystatin cream mixed with stomahesive powder to be applied to the area with crusting technique when the wafer was changed.She also suggested applying stomahesive barrier to the site with each wafer change and samples were sent.He reported a skin care routine of cleaning with water, he used another product of the company to remove the wafer.He was using a safe n simple barrier wipe when the redness started on his skin.The dermatologist recommended discontinuation of the product.The end user was using another product of the company with crusting technique of the nystatin/stomahesive powder and was now changing the wafer every 3 days.No photo available at this time.

Manufacturer Narrative

Photograph, video and/or physical sample evaluation: no photographs associated with this case were received and no unused return sample was expected.Batch record revision results: lot 0l03588 was manufactured on 28/nov/2020, in convex 2pc line, with a total of (b)(4) mkus.The complaint investigator performed a batch record review on 12/oct/2023, to verify if all the applicable procedures were followed and no issues were found; all the components for assembly were correct per bill of materials (bom) and all the tooling information documented was also correct, system application product (sap) material id 1156501 and manufacturing order (b)(4).The production process, in-process control, testing results and packaging of products was run according to the applicable process instruction (convex 2pc wafer sub-assembly machine 2 (collaring operations).Historical complaints review: on 12/oct/2023, complaint investigator ran a query in database from 01/jan/2022 to 03/oct/2023 in order to verify the complaints reported for the lot number 0l03588 for the malfunction code ¿no device malfunction determined based on complaint information provided (harm reported, other user/ clinical reasons for complaint" and as result, no additional complaints were found.Historical nonconformance review: on 12/oct/2023, complaint investigator ran a query in database looking for any in process nonconformance / corrective action / preventive actions (capa) (s) associated to the malfunction code ¿no device malfunction determined based on complaint information provided (harm reported, other user/ clinical reasons for complaint" for the lot number 0l03588 and as result, no nonconformance / capa (s) for this malfunction code were generated during the manufacturing process of the referenced lot.Defect rate analysis: there is no criteria not met, since during the investigation, this defect could not be attributed to the manufacturing process and there is no established a criterion for this type of defect.Conclusions: no objective evidence was received such as a photo or sample, for this reason, we cannot conclude that the product does not meet specifications.The review of the batch record showed that all relevant tests required during the manufacturing process and final product release had been fulfilled and met the requirements.No nonconformity has been registered during the manufacturing process of the affected lot for the malfunction code ¿no device malfunction determined based on complaint information provided (harm reported, other user/ clinical reasons for complaint)".No additional complaints were reported for lot affected related to the malfunction code ¿no device malfunction determined based on complaint information provided (harm reported, other user/ clinical reasons for complaint)"¿.Based on this, no negative trend was identified.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

To date no additional patient or event details have been received.

• Brand Name: L3O0200 - 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: 12726874
• MDR Text Key: 279250543
• Report Number: 9618003-2021-02635
• Device Sequence Number: 1
• Product Code: EXE
• UDI-Device Identifier: 00768455126675
• UDI-Public: 00768455126675
• 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,Followup
• Report Date: 10/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: 404593
• Device Lot Number: 0L03588
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 10/14/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/28/2020
• 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