MAUDE Adverse Event Report: CONVATEC DOMINICAN REPUBLIC INC L3O0350 - STOMAHESIVE; PROTECTOR, OSTOMY

Model Number	183910
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Codes	Erythema (1840); Fungal Infection (2419); Tissue Breakdown (2681); Blister (4537)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The event is considered misuse since the end user was using stomahesive paste and applied with a bead in the middle of the wafer mass whereas paste needs to be placed at the edge of the wafer opening or stoma junction.Also, end user was advised that it was not a glue.Instructions were provided to end user on stomahesive properties and indication to protect exposed skin between the base of the stoma and the opening of the skin barrier.The end user was also advised that it is not a glue but more of a caulking and is indicated to be placed at the edge of the wafer opening or stoma junction.It is thought that end user may have developed a skin allergy due to the misuse.(b)(6).Based on the available information, this event is deemed to be a reportable malfunction and 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.Fda registration number (b)(4).
Event or Problem Description
The end user reported to the retailer that the stomahesive paste caused peristomal blister, sores, redness, and oozing.She reported use of other company¿s two-piece flat pouching system with company¿s paste applied to mid mass circumferentially for several years without any issue.The end user was using company's paste was applied with a bead in the middle of the wafer mass.She clarified that she did not place the bead of paste at the inner opening where the barrier was sized to fit but she had been placing it in a circumferential bead towards to middle portion of the mass away from the stoma and barrier junction.She reported that over the most recent past month, she had experienced pouch leakage, which required her to change the appliance two to three times a day.Consumer further reported that the glue did not seem to hold and then he experienced skin irritation and a blister that opened which was about the size of a dime.Consumer reported that she did a follow up in the emergency room for evaluation approximately one week ago and she was given one dose of intravenous (iv) antibiotics and topical nystatin powder for yeast presence and advised to follow up with her primary care provider.Consumer had not yet scheduled an appointment with her provider, but she reported that the irritation and open blister were improving.Nystatin powder was reported to be applied to peristomal irritation site prior to pouch placement.A photograph depicting the issue was received from the complainant.

• Brand Name: L3O0350 - STOMAHESIVE
• 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: 14984354
• Report Number: 9618003-2022-00648
• Device Sequence Number: 16543373
• Product Code: EXE
• UDI-Device Identifier: 00768455150793
• UDI-Public: 00768455150793
• Combination Product (Y/N): N
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/13/2022

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: Other
• Device Model Number: 183910
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/13/2022
• Initial Report FDA Received Date: 07/12/2022
• 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