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

Model Number	413418
Medical Device Problem Codes	Material Too Rigid or Stiff (1544); Positioning Problem (3009)
Health Effect - Clinical Code	Skin Inflammation/ Irritation (4545)
Type of Reportable Event	Malfunction
Event or Problem Description
The consumer's daughter suspected that six or so moldable wafers were stiffer and more difficult to mold out of unknown number of boxes with unknown lot.Daughter was not currently with end user.She was unsure if they came from home health or the rehabilitation facility.She wondered, if they might be old.Her mother had leakage with associated skin irritation, but she was unsure if it was related to the wafer concern.Her wear time decreased now to two days which was up to four days.Her output could be liquid.The end user continued using the product.No photo is available at this time.
Event or Problem Description
The consumer's daughter suspected that six or so moldable wafers were stiffer and more difficult to mold out of unknown number of boxes with unknown lot.Daughter was not currently with end user.She was unsure if they came from home health or the rehabilitation facility.She wondered, if they might be old.Her mother had leakage with associated skin irritation, but she was unsure if it was related to the wafer concern.Her wear time decreased now to two days which was up to four days.Her output could be liquid.The end user 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
• 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: 13554632
• Report Number: 9618003-2022-00195
• Device Sequence Number: 14420022
• Product Code: EXE
• UDI-Device Identifier: 00768455124008
• UDI-Public: 00768455124008
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/18/2022

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: Other
• Device Model Number: 413418
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/18/2022
• Initial Report FDA Received Date: 02/17/2022
• 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