MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-31 for SURGICAL MESH manufactured by .
[188655280]
This mdr report is to follow up on record id (b)(4), originally reported in the 2019 asr report for december 2018-january 2019, under product code oto / exemption # e2014015. The device lot number, and implant/explant dates have been updated in section d of this report. Patient age has been added to this report. 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
[188655281]
This mdr report is to follow up on record id (b)(4), originally reported in the 2019 asr report for december 2018-january 2019, under product code oto / exemption # e2014015. The additional event description has been updated below. The device lot number, and implant/explant dates have been updated in section d of this report. Patient age has been added to this report. As reported to coloplast though not verified, the patient's legal representative stated severe emotional pain and injury, significant mental and physical pain and suffering. Bleeding and erosion were also noted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2125050-2020-00080 |
| MDR Report Key | 9653688 |
| Date Received | 2020-01-31 |
| Date of Report | 2020-01-21 |
| Date Added to Maude | 2020-01-31 |
| 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 | 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 55411 |
| Manufacturer Country | US |
| Manufacturer Postal | 55411 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | SURGICAL MESH |
| Product Code | OTO |
| Date Received | 2020-01-31 |
| Lot Number | 4845855 |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-31 |