MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-07-27 for SKATER? SINGLE STEP DRAINAGE SET 10FR X 25CM 756010025 manufactured by Argon Medical Devices Inc..
| Report Number | 1625425-2019-00217 |
| MDR Report Key | 8834409 |
| Date Received | 2019-07-27 |
| Date of Report | 2019-07-04 |
| Date of Event | 2019-06-04 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2005-01-14 |
| Device Manufacturer Date | 2018-10-16 |
| Date Added to Maude | 2019-07-27 |
| 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 | MS. GAIL SMITH |
| Manufacturer Street | 1445 FLAT CREEK ROAD |
| Manufacturer City | ATHENS TX 75751 |
| Manufacturer Country | US |
| Manufacturer Postal | 75751 |
| Manufacturer Phone | 2144368995 |
| Manufacturer G1 | ARGON MEDICAL DEVICES INC. |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | SKATER? SINGLE STEP DRAINAGE SET 10FR X 25CM |
| Generic Name | DRAINAGE CATHETERS |
| Product Code | GBQ |
| Date Received | 2019-07-27 |
| Returned To Mfg | 2019-07-18 |
| Catalog Number | 756010025 |
| Lot Number | 11234376 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARGON MEDICAL DEVICES INC. |
| Manufacturer Address | 1445 FLAT CREEK ROAD ATHENS TX 75751 US 75751 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-07-27 |