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

Model Number 416737

Device Problems Material Deformation (2976); Sharp Edges (4013)

Patient Problem No Patient Involvement (2645)

Event Date 01/13/2021

Event Type  malfunction  

Manufacturer Narrative

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

It was reported that in 1 out of sample pack of 3 appliances, the starter hole was jagged and where it was jagged, the mass felt uneven/rippled on the non-skin side of the mass.The product was not used on patient.A photograph depicting the issue was received from the complainant.

Manufacturer Narrative

The emdr with manufacturer report number (mdr 9618003-2021-00174), submitted on 02/05/2021 was submitted in error as this case was determined to be not reportable.Please retract the report.Correction (g1) - contact office address: (b)(6).(b)(6).(b)(6).(b)(6).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

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
• MDR Report Key: 11284628
• MDR Text Key: 230450189
• Report Number: 9618003-2021-00174
• 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: company representative
• Type of Report: Initial,Followup
• Report Date: 01/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 416737
• Device Lot Number: 9J00533
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 09/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1