MAUDE Adverse Event Report: CONVATEC DOMINICAN REPUBLIC INC L3O0675 - ESTEEM+; POUCH, COLOSTOMY

Model Number 416740

Device Problems Malposition of Device (2616); Positioning Problem (3009)

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

Event Type  malfunction  

Manufacturer Narrative

Device 1 of 2.(b)(4).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

The end user's daughter reported that the end user received shipment of pouches where the pre-cut hole was off centered and misshaped in 7 market units with the same lot number.The daughter stated some were worse than others, ones she tried to wear had reduced wear time and some she changed 3 or 4 times in a day, but others were just so far off she couldn't get the pouch to work if she had tried those, so she threw those away.The end user's daughter did not have any specific numbers for what was worn and what was discarded.No photo is available at this time.

Manufacturer Narrative

Correction (g1) - contact office address: (b)(6) batch record review results: lot 0m00978 was manufactured on 12/10/2020 in the cvx1pc manufacturing line, with a total of 272 mkus.On 19/aug/2021, 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.No issues related to the defect were found in the documentation.On 19/aug/2021 a complaint search for lot 0m00978 and malfunction code ost-pmc1.8 / ost-pmc01.08 skin barrier starter hole is defective (e.G misalignment or off center), leakage may occur (pre-cut only) was carried out and as a result, no additional complaints were found; therefore, no potential trend is observed.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: L3O0675 - ESTEEM+
• 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
• MDR Report Key: 12317489
• MDR Text Key: 266384380
• Report Number: 9618003-2021-01660
• 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: other
• Type of Report: Initial,Followup
• Report Date: 07/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 416740
• Device Lot Number: 0M00978
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 08/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1