MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-18 for RESTORELLE Y SHAPED manufactured by .
[188372717]
This mdr is created as a follow-up to record (b)(4), initially reported on product code oto asr exemption # e2014015 for (b)(6) 2019-(b)(6) 2019. This mdr is to reflect the additional information to be added to the "intial" asr report (patient information). Coloplast has not been provided any corroborating evidence to verify the information contained in this report.
Patient Sequence No: 1, Text Type: N, H10
[188372718]
This mdr is created as a follow-up to record (b)(4), initially reported on product code oto asr exemption # e2014015 for (b)(6) 2019-(b)(6) 2019. This mdr is to reflect the additional information to be added to the intial asr report.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2125050-2020-00259 |
| MDR Report Key | 9849900 |
| Date Received | 2020-03-18 |
| Date of Report | 2020-03-17 |
| Date Added to Maude | 2020-03-18 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | SARAH O'GARA |
| Manufacturer Street | 1601 WEST RIVER ROAD NORTH |
| Manufacturer City | MINNEAPOLIS, MN |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RESTORELLE Y SHAPED |
| Generic Name | SURGICAL MESH |
| Product Code | OTO |
| Date Received | 2020-03-18 |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-18 |