MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-26 for PROKERA PKCLR N/A manufactured by Tissue Tech, Inc..
| Report Number | 3003415347-2020-00001 |
| MDR Report Key | 9885441 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-03-26 |
| Date of Report | 2020-03-19 |
| Date of Event | 2020-01-20 |
| Date Mfgr Received | 2020-03-02 |
| Device Manufacturer Date | 2019-01-16 |
| Date Added to Maude | 2020-03-26 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. LORRAINE CHUA |
| Manufacturer Street | 7300 CORPORATE CENTER DR SUITE 700 |
| Manufacturer City | MIAMI FL 33126 |
| Manufacturer Country | US |
| Manufacturer Postal | 33126 |
| Manufacturer Phone | 7864567719 |
| Manufacturer G1 | TISSUE TECH, INC. |
| Manufacturer Street | 8305 NW 27TH ST |
| Manufacturer City | DORAL FL 33122 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 33122 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PROKERA |
| Generic Name | PROKERA CLEAR |
| Product Code | NQB |
| Date Received | 2020-03-26 |
| Model Number | PKCLR |
| Catalog Number | N/A |
| Lot Number | BTR180460 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TISSUE TECH, INC. |
| Manufacturer Address | 8305 NW 27TH ST SUITE 101 DORAL FL 33122 US 33122 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-03-26 |