MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2020-01-29 for SKATER SINGLE STEP DRAINAGE SET 756506025 manufactured by Argon Medical Devices Inc..
[183516350]
The customer has indicated that the sample device is available for return. A third request for the return of the device was sent on 1/22/2020. An evaluation will be conducted once argon has received the device. A follow-up report with additional information will be provided by 2/21/2020.
Patient Sequence No: 1, Text Type: N, H10
[183516351]
After the pigtail was placement finished and the patient was go back to the ward of the hospital observation rest. The next day, the customer occurred the pigtail was broken and they exam the pigtail. They found the white hub lower edge of pigtail connect with main body place was broken. Therefore, theyremoved the pigtail.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1625425-2020-00069 |
| MDR Report Key | 9644281 |
| Report Source | DISTRIBUTOR |
| Date Received | 2020-01-29 |
| Date of Report | 2020-01-02 |
| Date of Event | 2019-12-04 |
| 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 |
| Date Added to Maude | 2020-01-29 |
| 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 SINGLE STEP DRAINAGE SET |
| Generic Name | SKATER DRAINAGE CATHETER |
| Product Code | GBQ |
| Date Received | 2020-01-29 |
| Catalog Number | 756506025 |
| Lot Number | 11261220 |
| 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 | 2020-01-29 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Manufacturer | MANUFACTURE / COMPOUNDER NAME |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-01-29 |