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

Model Number 416747

Device Problem Sharp Edges (4013)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Device 4 of 12.(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

The end user reported that the pre-cut hole in 40 percent of the boxes had irregularities (jaggered edges) that were rough on the skin.The end user had used the affected products and there was no harm reported.No photo is available at this time.

Manufacturer Narrative

Correction (g1) - contact office address: (b)(6).Returned sample evaluation: no photo related to the reported problem is available for evaluation.Investigation summary: type 2 ost-pmc1.14 skin barrier in contact with skin is too rough or sharp, sharp edges at stoma may occur.On 15/feb/2021 a query was run by complaint investigator (b)(4) from 01/jan/2018 up to 18/feb/2021 in trackwise 8.7 system, associated to malfunction ost-pmc1.14 skin barrier in contact with skin is too rough or sharp, sharp edges at stoma may occur and six (6) complaints were identified.Wafer feels thinner resulting in a laceration of the stoma and no consistency with flanges, some are not central and irregularities with the pre-cut hole having jiggered edges.What is the extend of the nc? this document has been created to perform the preliminary investigation for complaints, lot number, icc and sap material listed in attachment#1 with malfunction ost-pmc1.14 skin barrier in contact with skin is too rough or sharp, sharp edges at stoma may occur, with severity rating 4.The scope of this nonconformance report is to cover the al products manufactured in the mlk#2, mlk#3, mlk#6ann convex 2pc auto lines.The following figure#1 shows the manufacturing lines with eight (8) complaints reported related to malfunction code ost-pmc1.14 from 01/jan/2018 up to 18/feb/2021.The figure#2 below shows complaints reported by manufacturing date from 01/jan/2018 up to 18/feb/2021 with malfunction code ost-pm1c.14: batch records review: batch records review was performed by complaint investigator (b)(4) for the affected lots number listed in the attachment#1.A total of five (5) lots number were verified to confirm if all the applicable procedures were followed and no issues were found; all the components for assembly were correct per bom and all the tooling information documented.Process description: the wafer used during the manufacturing process of the affected listed in attachment#1 are produced in elc#4 line.Pi31-033 (extrusion, lamination and cutting elc4) ver.19.0).Sticks of adhesive mass are placed in the opening of the extruder.The mass is carried by a screw through from the barrel chamber and pushed through an opening in the die.The extrudate is brought to the thickness specification and is then laminated between a top and bottom layer of silicone release paper.The top of the silicone release paper is removed, and a polyethylene film is used to laminate the adhesive surface.The three layers (paper, polyethylene and mass) are cooled and carried through a rotary cutter, where they are cut according to specifications.The finished wafers son inspected and stacked in trays to be placed in a finished product cart to await the next operation.The calender is adjusted to extrude the mass per process specifications, thickness test is performed before initiated the manufacturing process.Individual thickness test (including srp) is performed and must comply with the specification requirements 0.075" ± 0.005"1.91mm ± 0.127mm and for urihesive strips 0.071" ± 0.005"1.80mm ± 0.130mm.Thickness test was performed in elc#4 manufacturing line with satisfactory results 0.074mm, 0.75mm and 0.76mm within established requirements per pi31.033.The batch record review supports that there were no discrepancies related to the issue reported.History data review: two year query, since 01/jan/2018 up to 18/feb /2021 was run in trackwise system by complaint investigator (b)(4) to determine a trend of failure mode ost-pmc1.14 skin barrier in contact with skin is too rough or sharp, sharp edges at stoma may occur, six (6) complaints were identified and will be cover in this investigation.No trackwise record event (process ncrs) was identified during the period 01/jan/2018 up to 15/feb /2021.Preliminary investigation conclusion: based on the information above, no issues were identified during the manufacturing process as per the batch records review for the affected batches listed in attachment#1 and thickness test was performed per process specification with satisfactory results.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: 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: 10647365
• MDR Text Key: 210379931
• Report Number: 9618003-2020-14666
• 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,foreign
• Type of Report: Initial,Followup
• Report Date: 09/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 416747
• Device Lot Number: 0D01640
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 04/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1