MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-12-04 for SKATER SINGLE STEP DRAINAGE CATHETER W/LOCKING PIGTAIL 756508025 manufactured by Argon Medical Devices Inc..
[93584613]
Patient Sequence No: 1, Text Type: N, H10
[93584614]
The patient was having a catheter exchange for an abscess. It was discovered after the procedure that the plastic stiffener was retained inside the catheter. It seems it would be beneficial to have the cap of the stiffener be red to highlight that this is still in.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7078503 |
| MDR Report Key | 7078503 |
| Date Received | 2017-12-04 |
| Date of Report | 2017-11-29 |
| Date of Event | 2017-09-13 |
| Report Date | 2017-11-29 |
| Date Reported to FDA | 2017-11-29 |
| Date Reported to Mfgr | 2017-11-29 |
| Date Added to Maude | 2017-12-04 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SKATER SINGLE STEP DRAINAGE CATHETER W/LOCKING PIGTAIL |
| Generic Name | CATHETER, CONTINUOUS IRRIGATION |
| Product Code | GBQ |
| Date Received | 2017-12-04 |
| Catalog Number | 756508025 |
| ID Number | 8F X 25 CM, 17G TROCAR, ACCEP |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | 0 YR |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARGON MEDICAL DEVICES INC. |
| Manufacturer Address | 1445 FLAT CREEK RD. ATHENS TX 75751 US 75751 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-12-04 |