MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2020-03-31 for NATURA 413182 manufactured by Convatec Dominican Republic Inc.
[185980580]
Device 168 of 188. (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).
Patient Sequence No: 1, Text Type: N, H10
[185980583]
It was reported that 188 out of 460 wafers from the same lot had an off centered starter hole. The affected products were not used on patients. Photographs depicting the issue were received from the complainant.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9618003-2020-09202 |
| MDR Report Key | 9908956 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2020-03-31 |
| Date Mfgr Received | 2020-03-19 |
| Date Added to Maude | 2020-03-31 |
| 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 | 2020-03-31 |
| Model Number | 413182 |
| Lot Number | 9H04507 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2020-03-31 |