MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-11-08 for SADDLELOOP 18G X 10CM WITH BLUNT NEEDLE 1541 manufactured by Quest Medical, Inc.
[92605669]
This issue occurred outside of the us. Similar devices manufactured by quest medical are currently sold in the us. There were no patient complications resulting from this issue. An investigation will be completed and a follow up medwatch will be submitted if additional information becomes available.
Patient Sequence No: 1, Text Type: N, H10
[92605670]
A report was received from the distributor in (b)(4). The report states that the tensioner on the saddleloop came off from the tube in two separate procedures. There were no patient complications.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1649914-2017-00088 |
| MDR Report Key | 7011800 |
| Date Received | 2017-11-08 |
| Date of Report | 2018-01-17 |
| Date of Event | 2017-10-10 |
| Date Mfgr Received | 2017-10-15 |
| Date Added to Maude | 2017-11-08 |
| 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 | TOSAN ONOSODE |
| Manufacturer Street | ONE ALLENTOWN PARKWAY |
| Manufacturer City | ALLEN TX 75002 |
| Manufacturer Country | US |
| Manufacturer Postal | 75002 |
| Manufacturer Phone | 9723326338 |
| Manufacturer G1 | QUEST MEDICAL, INC |
| Manufacturer Street | ONE ALLENTOWN PARKWAY |
| Manufacturer City | ALLEN TX 75002 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 75002 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | SADDLELOOP 18G X 10CM WITH BLUNT NEEDLE |
| Generic Name | VASCULAR LOOP |
| Product Code | GAE |
| Date Received | 2017-11-08 |
| Returned To Mfg | 2017-10-18 |
| Model Number | 1541 |
| Lot Number | 0499345C01 |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | QUEST MEDICAL, INC |
| Manufacturer Address | ONE ALLENTOWN PARKWAY ALLEN TX 75002 US 75002 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-11-08 |