MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-05 for NATURA 402204 manufactured by Convatec Dominican Republic Inc.
[126381004]
(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. Fda registration number: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[126381005]
It was reported hole is not centered correctly so the edges overlap with the sticky surface, which makes it very difficult to attach the wafer to the skin. No photo was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9618003-2018-02580 |
| MDR Report Key | 8037733 |
| Date Received | 2018-11-05 |
| Date Mfgr Received | 2018-10-31 |
| Date Added to Maude | 2018-11-05 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. JEANETTE JOHNSON |
| Manufacturer Street | 7900 TRIAD CENTER DRIVE SUITE 400 |
| Manufacturer City | GREENSBORO NC 27409 |
| Manufacturer Country | US |
| Manufacturer Postal | 27409 |
| Manufacturer G1 | CONVATEC DOMINICAN REPUBLIC INC |
| Manufacturer Street | KM 18.5 PARQUE INDUSTRIAL ITABO, S.A. HAINA |
| Manufacturer City | SAN CRISTOBAL |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | NATURA |
| Generic Name | NOT APPLICABLE |
| Product Code | EXD |
| Date Received | 2018-11-05 |
| Model Number | 402204 |
| Lot Number | 8G01612 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CONVATEC DOMINICAN REPUBLIC INC |
| Manufacturer Address | KM 18.5 PARQUE INDUSTRIAL ITABO, S.A. HAINA SAN CRISTOBAL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-11-05 |