MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2019-11-30 for NATURA 404592 manufactured by Convatec Dominican Republic Inc.
[176476888]
(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. Device 303 of 1313. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[176476889]
It was reported by the retailer/distributor that " the hole of wfr is not in center". The product was not used, no harm reported. Photographs were received from the complainant depicting the reported complaint issue. Stock was reviewed and counted by the distributor.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 9618003-2019-12868 |
MDR Report Key | 9392115 |
Report Source | DISTRIBUTOR,FOREIGN |
Date Received | 2019-11-30 |
Date of Event | 2019-10-30 |
Date Mfgr Received | 2019-11-03 |
Date Added to Maude | 2019-11-30 |
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 Phone | 3365424681 |
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 | 3 |
Brand Name | NATURA |
Generic Name | PROTECTOR, OSTOMY |
Product Code | EXE |
Date Received | 2019-11-30 |
Model Number | 404592 |
Lot Number | 9A03366 |
Device Availability | N |
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 | 2019-11-30 |