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

Model Number 416742

Device Problem Malposition of Device (2616)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Device 2 of 3.(b)(6).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 the wafer came with off centered starter hole.The product was not used.No photo is available at this time.

Event Description

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

Manufacturer Narrative

(b)(6).This complaint has been reported as type 2.No samples or photos were received for analysis and investigation; for that reason, the malfunction reported by the customer could not be confirmed.On 10/may/2021, a batch record review was performed for lot 0h04069.Lot 0h04069 was manufactured on 8/29/2020 in the convex one piece line, with a total of 2,016 mku.Based on the review carried out, all the applicable procedures were followed and no issues were found; all the components for assembly were correct per bom, sap material 1703552, icc code 416742 and manufacturing order 1540669.The process was run according to process instruction pi21-076, documented in the mr21-076.Batch record review carried out supports that no issues related to the problem were identified.In addition, a complaint search for lot 0h04069 and malfunction code 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 trend for this lot is observed.As per complaint manufacturing investigation procedure wi-0359, version 5.0, it is not required to open a nonconformance report (ncr) for type 2 complaints which were not confirmed (either by photos or samples provided by the customers or results of the batch record review) and no potential trend is identified.Therefore, for all explained above, no additional action is required and this complaint 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: 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: 11342070
• MDR Text Key: 232332816
• Report Number: 9618003-2021-00247
• 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: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 01/25/2021

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: Other
• Device Model Number: 416742
• Device Lot Number: 0H04069
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 01/25/2021
• Initial Date FDA Received: 02/18/2021
• Supplement Dates Manufacturer Received: 05/10/2021
• Supplement Dates FDA Received: 07/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1