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

Model Number	413154
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Codes	Erythema (1840); Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943); Fungal Infection (2419); Tissue Breakdown (2681)
Type of Reportable Event	Serious Injury
Event or Problem Description
The end user was a long-time exclusive user of the product.She stated that approximately two weeks ago she started to develop red skin under the wafer that she described as red patches.She described an itching sensation with skin excoriation.She denied blister formation or bleeding.She reported that she had not experienced these symptoms in the past.She had a history of skin sensitivity to adhesives and had to patch test products with adhesives before using the product.She denied changes to her diet and medications.She stated that she had noticed some bulging under the stoma with sensations of tightness and had sought out advice from a surgeon to evaluate for possible parastomal hernia.She was wearing a convex insert with the current wafer due to a flush stoma.She also denied leakage of stool under the wafer.She was seen by a nurse and a dermatologist for skin evaluation.She was told by the dermatologist that she had a combination of skin issues due to yeast and skin sensitivity to the product.She was prescribed diflucan pills and an antifungal cream.She stated that her skin reacted (unable to tolerate) to an antifungal powder.She reported her skin preparation a peristomal cleaning routine of cleaning her skin in the shower, without using soap, just water.She does not use an adhesive remover wipe or skin protectant wipe.Her wear time for the product was seven days and changing the appliance after every seven days.She pictured frames around the wafer with a blue colored 3m medical tape.No photo is available at this time.
Event or Problem Description
To date no additional patient or event details have been received.
Additional Manufacturer Narrative
Batch record review results: the lot 1b02622 was manufactured on 02/20/2021, mlk-3 manufacturing line, with a total of (b)(4) market units.Complaint investigator id (b)(4) performed a batch record review on 08/12/2022 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 1159896 and manufacturing order (b)(4).The batch record review supports that there were no discrepancies related to the issue reported.On 08/12/2022 a complaint search for lot 1b02622 and malfunction code ost-pmc22.07 clinical misindication, enduser is using improper device for their medical condition and/or known risk factors was carried out and as a result, no additional complaints were found; therefore, no potential trend is observed.As per complaint manufacturing investigation procedure (b)(4), it is not required to open a nonconformance report (ncr) for type 2 complaints which were not confirmed and no potential trend is identified.In addition per phri, this complaint has been submitted to escalation for misuse.Because the end user has a history of skin sensitivity to adhesives, still using appliance.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.

• 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: 13652238
• Report Number: 9618003-2022-00236
• Device Sequence Number: 17580088
• Product Code: EXE
• UDI-Device Identifier: 00768455126514
• UDI-Public: 00768455126514
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/04/2022

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: 02/19/2026
• Device Model Number: 413154
• Device Lot Number: 1B02622
• 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: 02/04/2022
• Supplement Date Received by Manufacturer: 08/14/2022
• Initial Report FDA Received Date: 03/02/2022
• Supplement Report FDA Received Date: 08/15/2022
• Date Device Manufactured: 02/20/2021
• 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: Female