MAUDE Adverse Event Report: UNOMEDICAL S.R.O. L3O0215 - NATURA+; POUCH, COLOSTOMY

Model Number 421681

Device Problem Sharp Edges (4013)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

It was reported by veterans affairs (va) nurse who received an information from veterans affairs (va) pharmacist and sent an email to company concierge that end user was not her patient and she was getting the information from third party because end user was not answering the call.Nurse reported that the end user was using the legacy product that had been discontinued.He felt that the current product had sharp edges.The product was used by patient.No photo is available at this time.

Manufacturer Narrative

Initial reporter: complainant phone : (b)(6).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).

• Brand Name: L3O0215 - NATURA+
• Type of Device: POUCH, COLOSTOMY
• Manufacturer (Section D): UNOMEDICAL S.R.O.; priemyselny park 3,; michalovce 07101 ; LO 07101
• Manufacturer (Section G): UNOMEDICAL S.R.O.; priemyselny park 3,; michalovce 07101 ; LO 07101
• Manufacturer Contact: pamela meadows ; 7815 national service road; suite 600; greensboro, NC ; 3365424679
• MDR Report Key: 14045010
• MDR Text Key: 298477390
• Report Number: 3005778470-2022-00013
• Device Sequence Number: 1
• Product Code: EZQ
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/11/2022

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
• Device Operator: Lay User/Patient
• Device Model Number: 421681
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/11/2022
• Initial Date FDA Received: 04/07/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male