MAUDE Adverse Event Report: CONVATEC DOMINICAN REPUBLIC INC NATURA; NOT APPLICABLE

Model Number 402203

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.An investigation was performed to determine the root cause associated with the investigation wafer disc decentralization, complaint malfunction (skin barrier starter hole is defective, e.G.Misalignment or off center, leakage may occur), for lots manufactured in (b)(4).The cause and effect investigation was performed.  it was determined that the following probable root causes and opportunities were identified: machinery is the root cause of this incident.  it is concluded that all the machinery/ tooling items complied when compared against drawing specifications, however due to the demands of the process, these tooling require a dimension modification to reduce the variability of the process.Observations include:  misalignment of the wafer loading pins, misalignment of the upper wafer loading plate and fixation of the upper wafer loading plate and lower wafer loading plate.Actual testing method of (random hourly sampling) may not effectively capture the defects prior to packaging, it is suggested the implementation of a continuous testing method to anticipate to all of the peaks.A certification of the operators who have direct influence due to the ¿flange/wafer loading¿ process in operations, to reduce the learning curve effect in process and guarantee the training effectiveness.This should be performed in conjunct with the quality inspector, process engineer of such line and the supervisor.Actions will be taken for each factor and will be summarized on a corrective action / preventive actions (capa) plan.The investigation associated with this event is approved and complete.  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.(b)(4).

Event Description

It was reported that "precut hole off center." no harm reported.Photos depicting the reported complaint issue were provided by the complainant.

• Brand Name: NATURA
• 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: jeanette johnson ; 7900 triad center drive; suite 400; greensboro, NC 27409
• MDR Report Key: 7919779
• MDR Text Key: 122460117
• Report Number: 9618003-2018-01823
• 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: consumer,foreign
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/13/2022
• Device Model Number: 402203
• Device Lot Number: 7L01060
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/10/2018
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1