MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-14 for KIT RESTORELLE Y CONT MERIDIAN 5208102400 520810 manufactured by .
[188367115]
This mdr is created as a follow-up to record (b)(4), initially reported on product code otn asr exemption # e2014015 for (b)(6) 2018-(b)(6) 2019. This mdr is to reflect the additional information to be added to the intial asr report (patient information, product information). The lot number was reviewed for complaint trend, nonconforming report and capa review. No trends were noted. Coloplast has not been provided any corroborating evidence to verify the information contained in this report.
Patient Sequence No: 1, Text Type: N, H10
[188367116]
This mdr is created as a follow-up to record (b)(4), initially reported on product code otn asr exemption # e2014015 for (b)(6) 2018-(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 | 2125050-2020-00212 |
| MDR Report Key | 9833145 |
| Date Received | 2020-03-14 |
| Date of Report | 2020-03-05 |
| Date Added to Maude | 2020-03-14 |
| 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 | STEPHANIE PERRYMAN |
| 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 | KIT RESTORELLE Y CONT MERIDIAN |
| Generic Name | SURGICAL MESH |
| Product Code | OTO |
| Date Received | 2020-03-14 |
| Model Number | 5208102400 |
| Catalog Number | 520810 |
| Lot Number | 5169854 |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-14 |