MAUDE Adverse Event Report: CONVATEC DOMINICAN REPUBLIC INC EST+ DRNPRECUTINVISICLR38MM(1X10) NAI; NOT APPLICABLE

Model Number 421024

Device Problem Malposition of Device (2616)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(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 the starter hole was off center in three wafers.The product was not used and no photo was provided.

Manufacturer Narrative

Additional information - this emdr is being submitted to include the below: d4: unique identifier (udi).H6: investigation results under imdrf cause investigation code, imdrf investigation findings, imdrf cause conclusions.H10: investigation summary: no samples or photos were received for analysis and investigation; for that reason, the malfunction reported by the customer could not be confirmed.In addition, a complaint search for lot 8c03437 and malfunction 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 complaint was found; therefore, no trend is observed.As per complaint manufacturing investigation procedure it is not required to open a nonconformance report (ncr) for type 2 complaints which were not confirmed.Lot 8c03437 was manufactured on 04/13/2018, aps manual 3 line, with a total of (b)(4) units.Complaint investigator performed a batch record review on 09/28/2020, est+ drnprecutinvisiclr38mm(1x10) nai to verify if all the applicable procedures were followed and no issues were found; all the components for assembly were correct per bill of materials (bom) and all the tooling information documented was also correct.System application product (sap) material 1709643 and manufacturing order (b)(4).The batch record review supports that there were no discrepancies related to the issue reported.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.

Event Description

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

• Brand Name: EST+ DRNPRECUTINVISICLR38MM(1X10) NAI
• Type of Device: NOT APPLICABLE
• Manufacturer (Section D): CONVATEC DOMINICAN REPUBLIC INC; km 18.5 parque industrial; itabo, s.a. haina; san cristobal
• Manufacturer (Section G): CONVATEC DOMINICAN REPUBLIC INC; km 18.5 parque industrial; itabo, s.a. haina; san cristobal
• Manufacturer Contact: pamela meadows ; 7815 national service road; suite 600; greensboro, NC 27409 ; 3365424679
• MDR Report Key: 8115744
• MDR Text Key: 128894154
• Report Number: 9618003-2018-03652
• Device Sequence Number: 1
• Product Code: EXB
• Combination Product (y/n): N
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup

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 Expiration Date: 04/12/2023
• Device Model Number: 421024
• Device Lot Number: 8C03437
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 11/12/2018
• Initial Date FDA Received: 11/29/2018
• Supplement Dates Manufacturer Received: 08/02/2023
• Supplement Dates FDA Received: 08/08/2023
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1