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

Model Number 416740

Device Problem Malposition of Device (2616)

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

Event Type  malfunction  

Manufacturer Narrative

(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 pre-cut hole of 1 appliance was off centered and misshappened.The product was not used and no photo is available at this time.

Event Description

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

Manufacturer Narrative

(b)(6).Batch record review results: lot 0j00168 was manufactured on 09/06/2020 in the cvx1pc manufacturing line, with a total of (b)(4) 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 0j00168 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.

• 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: 12286542
• MDR Text Key: 265338187
• Report Number: 9618003-2021-01664
• 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

• 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: 0J00168
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 07/20/2021
• Initial Date FDA Received: 08/06/2021
• Supplement Dates Manufacturer Received: 08/19/2021
• Supplement Dates FDA Received: 08/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1