MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2018-06-08 for ESTEEM SYNERGY 403986 manufactured by Convatec Dominican Republic Inc.
[110581519]
(b)(6). Based on the available information, this event is deemed to be a reportable malfunction. No lot number is available. A detailed investigation or batch review cannot be conducted. Therefore, this evaluation 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. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[110581520]
The distributor reported the skin barrier starter hole was defective (off center). The device was not used. No further information or photograph was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9618003-2018-00305 |
| MDR Report Key | 7584275 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2018-06-08 |
| Date Mfgr Received | 2018-05-15 |
| Date Added to Maude | 2018-06-08 |
| 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 | 3 |
| Brand Name | ESTEEM SYNERGY |
| Generic Name | APPLIANCE, COLOSTOMY, DISPOSABLE |
| Product Code | EZS |
| Date Received | 2018-06-08 |
| Model Number | 403986 |
| 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 | 2018-06-08 |