MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2020-03-04 for SKATER INTRODUCER SYSTEM 651506300 manufactured by Argon Medical Devices Inc..
[185004749]
The sample device is indicated as available for evaluation. However, as of the date of this report the device has not yet been returned. A follow-up report will be provided by 4/3/2020.
Patient Sequence No: 1, Text Type: N, H10
[185004750]
During placement of a drainage catheter, the distal coil of the 0. 018? Guidewire suspected strip off the core.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1625425-2020-00202 |
| MDR Report Key | 9788709 |
| Report Source | DISTRIBUTOR |
| Date Received | 2020-03-04 |
| Date of Report | 2020-02-20 |
| Date of Event | 2020-01-16 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2020-02-20 |
| Date Added to Maude | 2020-03-04 |
| 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 | 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 | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SKATER INTRODUCER SYSTEM |
| Generic Name | SKATER INTRODUCER |
| Product Code | GCB |
| Date Received | 2020-03-04 |
| Catalog Number | 651506300 |
| Lot Number | 11271397 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARGON MEDICAL DEVICES INC. |
| Manufacturer Address | 1445 FLAT CREEK ROAD ATHENS TX 75751 US 75751 |
| Brand Name | ACETAMINOPHEN 500MG |
| Product Code | --- |
| Date Received | 2020-03-04 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Manufacturer | MANUFACTURE / COMPOUNDER NAME |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-04 |