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

Model Number	413156
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erythema (1840); Necrosis (1971); Ulcer (2274); Tissue Breakdown (2681); Fluid Discharge (2686); Skin Inflammation/ Irritation (4545)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Correction (mfr site) contact office address: (b)(4).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.(b)(4).
Event or Problem Description
The end user's wife reported that the wafer was working well and lasted almost a week.However, she also reported red sore under mass approximately 0.5-1 inch away from the stoma at the 7-8 o'clock position.She stated that it was approximately the size of a silver dollar and was red with a dime-sized black center.The area was draining.It started approximately 1 week ago with the redness area and drainage but she first noted the black area on the day of this report.She was using stomahesive powder and an unknown brand barrier wipe as well as eakin.She was not alleging that the product caused the sore.She was unsure of the cause.The end user's wife had contacted the physician but had not yet received a response but stated that she will do so again on the day of this report and the end user continued to use the product.

• 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
• MDR Report Key: 12479759
• Report Number: 9618003-2021-02255
• Device Sequence Number: 17672018
• Product Code: EXE
• UDI-Device Identifier: 00768455126538
• UDI-Public: 00768455126538
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 08/18/2021

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: Other
• Device Model Number: 413156
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/18/2021
• Initial Report FDA Received Date: 09/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60