MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2020-02-05 for PROCTO SWAB 31-249 manufactured by Goodwood Medical Care Ltd.
| Report Number | 3010452421-2020-00001 |
| MDR Report Key | 9673511 |
| Report Source | DISTRIBUTOR |
| Date Received | 2020-02-05 |
| Date of Report | 2020-02-05 |
| Date of Event | 2019-03-28 |
| Date Mfgr Received | 2020-01-09 |
| Date Added to Maude | 2020-02-05 |
| 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 | SARAH BENNETT |
| Manufacturer Street | 200 DEBUSK LANE |
| Manufacturer City | POWELL TN 37849 |
| Manufacturer Country | US |
| Manufacturer Postal | 37849 |
| Manufacturer Phone | 8653626112 |
| Manufacturer G1 | ORTHO AND SURGICAL PRODUCTS ENTERPRISES S.A. |
| Manufacturer Street | KM 20.5 CARRETERA A VILLA CANALES,ZONA 3 FINCA MORANCITO |
| Manufacturer City | VILLA CANALES, GUATEMALA 01065 |
| Manufacturer Country | GT |
| Manufacturer Postal Code | 01065 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PROCTO SWAB |
| Generic Name | APPLICATOR, ABSORBENT TIPPED, STERILE |
| Product Code | KXG |
| Date Received | 2020-02-05 |
| Model Number | 31-249 |
| Lot Number | 47346703 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GOODWOOD MEDICAL CARE LTD |
| Manufacturer Address | 1-2 FLOOR, 3-919 JIULICUN YONGZHENG STREET, JINZHOU DIST DALIAN, LIAONING 116100 CH 116100 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-05 |