MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,user facility report with the FDA on 2018-11-21 for SKATER? SINGLE-STEP DRAINAGE CATHETER SET WITH LOCKING PIGTAIL 756506025 manufactured by Argon Medical Devices Inc..
[128020727]
The evaluation of this issue is in progress. A follow-up report will be submitted once the investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
[128020728]
Due to resistance, it was not able to pull the thread out when removing the catheter after drainage of one month period. The thread was cut close to the skin surface and the remaining thread was left in the patient body. The catheter had placed in a gal balder for a month for drainage. No extra procedure or surgery is planed to remove the remaining thread from the body.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1625425-2018-00186 |
| MDR Report Key | 8093603 |
| Report Source | DISTRIBUTOR,USER FACILITY |
| Date Received | 2018-11-21 |
| Date of Report | 2018-11-21 |
| Date of Event | 2018-10-04 |
| 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 | 2018-02-14 |
| Date Added to Maude | 2018-11-21 |
| 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 | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SKATER? SINGLE-STEP DRAINAGE CATHETER SET WITH LOCKING PIGTAIL |
| Generic Name | DRAINAGE CATHETERS |
| Product Code | GBQ |
| Date Received | 2018-11-21 |
| Returned To Mfg | 2018-11-07 |
| Catalog Number | 756506025 |
| Lot Number | 11207840 |
| 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. Other | 2018-11-21 |