MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-07-26 for TBL201 manufactured by Pajunk Medical Sysytems, Lp.
| Report Number | 3004076349-2019-00002 |
| MDR Report Key | 8833693 |
| Date Received | 2019-07-26 |
| Date of Report | 2019-07-26 |
| Date of Event | 2019-07-09 |
| Date Mfgr Received | 2019-07-09 |
| Date Added to Maude | 2019-07-26 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. MARCO WOHNIG |
| Manufacturer Street | 6611 BAY CIRCLE, STE. 140 |
| Manufacturer City | NORCROSS GA 30071 |
| Manufacturer Country | US |
| Manufacturer Postal | 30071 |
| Manufacturer Phone | 7704936832 |
| Manufacturer G1 | PAJUNK MEDICAL SYSYTEMS, LP |
| Manufacturer Street | 6611 BAY CIRCLE STE. 140 |
| Manufacturer City | NORCROSS GA 30071 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 30071 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | TBL201 |
| Generic Name | SPINAL ANESTHESIA KIT |
| Product Code | OFU |
| Date Received | 2019-07-26 |
| Model Number | TBL201 |
| Catalog Number | TBL201 |
| Lot Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PAJUNK MEDICAL SYSYTEMS, LP |
| Manufacturer Address | 6611 BAY CIRCLE STE. 140 NORCROSS GA 30071 US 30071 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-07-26 |