MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-02-13 for JACKSON PRATT 7MM FLAT DRAIN FULL PERF SU130-1310 manufactured by Pr006 Puerto Rico-anasco.
| Report Number | 1423537-2020-00413 |
| MDR Report Key | 9708502 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-02-13 |
| Date of Report | 2020-03-20 |
| Date of Event | 2019-12-19 |
| Date Mfgr Received | 2020-01-16 |
| Date Added to Maude | 2020-02-13 |
| 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 | PATRICIA TUCKER |
| Manufacturer Street | 3651 BIRCHWOOD DRIVE |
| Manufacturer City | WAUKEGAN IL 60085 |
| Manufacturer Country | US |
| Manufacturer Postal | 60085 |
| Manufacturer Phone | 8478874151 |
| Manufacturer G1 | PR006 PUERTO RICO-ANASCO |
| Manufacturer Street | STATE RD. 402 , NORTH KM 0.9 |
| Manufacturer City | ANASCO PR 00610 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 00610 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | JACKSON PRATT 7MM FLAT DRAIN FULL PERF |
| Generic Name | CATHETER, IRRIGATION |
| Product Code | GBX |
| Date Received | 2020-02-13 |
| Model Number | SU130-1310 |
| Catalog Number | SU130-1310 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PR006 PUERTO RICO-ANASCO |
| Manufacturer Address | STATE RD. 402 , NORTH KM 0.9 ANASCO PR 00610 US 00610 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-13 |