MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-10 for PROKERA OPHTHALMIC BIOLOGICAL TISSUE manufactured by Tissuetech, Inc..
[178961354]
Blue rubber ring detached from prokera clear in pt's eye. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5092924 |
| MDR Report Key | 9695001 |
| Date Received | 2020-02-10 |
| Date of Report | 2020-02-06 |
| Date of Event | 2020-01-20 |
| Date Added to Maude | 2020-02-11 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PROKERA OPHTHALMIC BIOLOGICAL TISSUE |
| Generic Name | COMFORMER, OPHTHALMIC BIOLOGIC TISSUE |
| Product Code | NQB |
| Date Received | 2020-02-10 |
| Lot Number | 19PKCLR00159 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TISSUETECH, INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-02-10 |