MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-06-26 for ENDO-SOF AQ DOUBLE PIGTAIL STENT SET N/A DPSCS-080026-AQ-R manufactured by Cook Inc.
[78555550]
(b)(4). The event is currently under investigation. A follow-up report will be submitted upon receipt of additional information or completion of the investigation.
Patient Sequence No: 1, Text Type: N, H10
[78555551]
It was reported that prior to performing an unspecified procedure, the physician opened a package containing endo-sof aq double pigtail stent set and found that the distal end of the stent was torn. The device did not come in contact with the patient. The physician completed the procedure using another of the same device. According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2017-01518 |
| MDR Report Key | 6666926 |
| Date Received | 2017-06-26 |
| Date of Report | 2018-02-06 |
| Date of Event | 2017-05-25 |
| Date Mfgr Received | 2018-01-23 |
| Device Manufacturer Date | 2017-03-27 |
| Date Added to Maude | 2017-06-26 |
| 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 | MR. LARRY POOL |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal | 47404 |
| Manufacturer Phone | 8123392235 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ENDO-SOF AQ DOUBLE PIGTAIL STENT SET |
| Product Code | EYB |
| Date Received | 2017-06-26 |
| Model Number | N/A |
| Catalog Number | DPSCS-080026-AQ-R |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK INC |
| Manufacturer Address | 750 DANIELS WAY BLOOMINGTON IN 47404 US 47404 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-06-26 |