MAUDE Adverse Event Report: CONVATEC DOMINICAN REPUBLIC INC NATURA; POUCH, COLOSTOMY

Model Number 401934

Device Problems Material Erosion (1214); Leak/Splash (1354)

Patient Problems Abrasion (1689); Hemorrhage/Bleeding (1888)

Event Type  malfunction  

Event Description

This emdr is being submitted for unknown number of wafers with unknown lot number and quantity unknown.The end user reported that company¿s products were not the same quality as they were years ago, and the wafers did not turtleneck like it used to.He mentioned that, the company¿s known wafer eroded away which left a thin plastic exposed.This also allowed leakage to occur on to his skin.This plastic rubbed against the end user's stoma and caused it to bleed (small amount).He did not see a cut or laceration on the stoma.The bleeding had stopped with pressure.Furthermore, he reported that there was no change in stoma or routine otherwise.No photo was available at this time.

Manufacturer Narrative

A2: age at the time of event - 81 years.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.

• Brand Name: NATURA
• Type of Device: POUCH, COLOSTOMY
• 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: 16812753
• MDR Text Key: 313995255
• Report Number: 9618003-2023-00325
• 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: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 401934
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/31/2023
• 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: Male