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

Model Number	125260
Medical Device Problem Code	Sharp Edges (4013)
Health Effect - Clinical Code	Erythema (1840)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device 6 of 7.Correction - contact office address: (b)(4).Based on the available information, this event is deemed to be a reportable malfunction.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
It was reported that the wafers became hard approximately 24 hours after application.The opening surrounding the stoma then felt it was sharp and put pressure around the stoma.Once the wafer was removed, the pain would immediately go away.There was no visible injury to the stoma noted but some redness was noted at the mucocutaneous junction.The redness resolved on its own without treatment.She stated that this occurred with most of the last market unit.For skin care the end user was cleansing with ivory soap and was also using adapt paste.The packaging was discarded and the lot number could not be retrieved.She further stated that this was not occurring with the current market unit and continued using the product.No photo is available at this time.

• 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: 12583043
• Report Number: 9618003-2021-02548
• Device Sequence Number: 1295998
• Product Code: EXE
• UDI-Device Identifier: 00768455125395
• UDI-Public: 00768455125395
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): 09/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: 125260
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/07/2021
• Initial Report FDA Received Date: 10/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1