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

Model Number 413179

Device Problems Material Separation (1562); Malposition of Device (2616)

Patient Problems Rash (2033); Skin Irritation (2076)

Event Type  malfunction  

Manufacturer Narrative

Based on the available information, this event is deemed to be a reportable malfunction.To date no additional information has been received.Should additional information become available, a follow-up report will be submitted.(b)(4).

Event Description

It was reported the mass is very off centered and within 2-3 days the mass is separating from the tape collar which is causing the wafer to leak.Due to the frequent leaking on the end user's skin, she has developed skin irritation with red rash.No photo provided.

Manufacturer Narrative

Batch record review: lot 8k03326 was manufactured on 10/31/2018, line convex 2 pc 2 with a total of (b)(4) market units.A batch record review was performed 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, under icc code (b)(4), sap material (b)(4) and manufacturing order (b)(4).The batch record review supports that there were no discrepancies related to the issue reported.There are no photographs associated with this case and no unused return sample was expected.Investigation conclusion: based on the investigation findings through revision of the batch records documentation, process observation, personnel interviewed, methodology implemented and defects simulation, the specific root cause could not be identified.Never the less, there are seven (07) conditions that could be considered, based on objective evidences and expertise, as contributor factors for this event and, one (01) opportunities for improvement were found: materials investigations: fabric rolls not rolled uniformly, no welded or over welded flanges.Process/methods investigation wrong adhesive tape used for joint fabrics rolls.Opportunities for improvement: introduce qc tooling used for quality inspection purpose in the calibration program to guarantee measurement assurance.Machinery / equipment/ software investigation: different movement relation vs cardan in the yamaha arm pads if the cognex cameras of the vision system is not clean in the vision system, the model in the system is not centralized when the yamaha is not adjusted if the web index is moved, due to the positioning of the vision system.Should additional information become available, a follow-up report will be submitted.Fda registration number: reporting site: 1049092, manufacturing site: 9618003.

Event Description

To date no additional patient or event details have been received.

• Brand Name: NATURA
• Type of Device: PROTECTOR, OSTOMY
• Manufacturer (Section D): CONVATEC DOMINICAN REPUBLIC INC; km 18.5 parque industrial; itabo, s.a. haina; san cristobal
• Manufacturer (Section G): CONVATEC DOMINICAN REPUBLIC INC; km 18.5 parque industrial; itabo, s.a. haina; san cristobal
• Manufacturer Contact: pamela meadows ; 7815 national service road; suite 600; greensboro, NC 27409 ; 3365424679
• MDR Report Key: 8771677
• MDR Text Key: 150413778
• Report Number: 9618003-2019-04647
• Device Sequence Number: 1
• Product Code: EXE
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/30/2023
• Device Model Number: 413179
• Device Lot Number: 8K03326
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 10/12/2023
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Sex: Female