MAUDE Adverse Event Report: CONVATEC DOMINICAN REPUBLIC INC NATURA+; BAG, URINARY, ILEOSTOMY

Model Number 421739

Device Problem Sharp Edges (4013)

Patient Problem Discomfort (2330)

Event Type  malfunction  

Manufacturer Narrative

Mdr 9618003-2023-00495 / device 4 of 6.A2: age at the time of event - 93 years.D4: the consumer transitioned from ref 413335.However, it is an unknown model number of to be determined aps pouches, assumed to be 421739.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.Fda registration number.Reporting site: 1049092.Manufacturing site: 9618003.

Event Description

The consumer is a ninety-three-year-old female with an ileostomy since 1972.She threw her boxes away, therefore, no lot number was available.The consumer reported that the belt tabs on approximately six pouches with unknown lot and reference number, felt sharp to her and were digged into her skin which caused sensation.However, no physical harm was noted.Further, she stated that she immediately removed the pouch and applied a new one.She denied skin breakdown or any form on trauma to the skin from the belt tabs and did not wear a belt.The products were not returned.No photo was available at this time.

• Brand Name: NATURA+
• Type of Device: BAG, URINARY, ILEOSTOMY
• 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: 16875439
• MDR Text Key: 314648181
• Report Number: 9618003-2023-00495
• Device Sequence Number: 1
• Product Code: EXH
• 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
• Report Date: 04/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 421739
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/11/2023
• 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: Female