MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-06-13 for SCLEROTHERAPY NEEDLE 2040LC manufactured by Telemed Systems Inc..
[77416445]
Patient Sequence No: 1, Text Type: N, H10
[77416446]
Nurse reported that during this procedure, the nurse introduced a sclerotherapy needle to the field; when it was being advanced down the endoscope, the physician noticed that the covering had become partially removed exposing the inner metal device. This product was withdrawn and a new device used. The area of concern did not reach the patient and the endoscope was not harmed. The device was saved and will be released to the company representative on wednesday. (for the convenience of the company's review) pictures will be sent separate from this report to the fda. Manufacturer response for sclerotherapy needle, sclerotherapy needle 25ga x 5mm (per site reporter): i will include the reps name prior to closing this event for final submission. The device is disposable. The device and package will be released to company rep the company is telemed. I put the package pic and the lot # and exp date into the sr.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6636219 |
| MDR Report Key | 6636219 |
| Date Received | 2017-06-13 |
| Date of Report | 2017-06-12 |
| Date of Event | 2017-06-07 |
| Report Date | 2017-06-12 |
| Date Reported to FDA | 2017-06-12 |
| Date Reported to Mfgr | 2017-06-12 |
| Date Added to Maude | 2017-06-13 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | SCLEROTHERAPY NEEDLE |
| Generic Name | ENDOSCOPIC INJECTION NEEDLE, GASTROENTEROLOGY-UROLOGY |
| Product Code | FBK |
| Date Received | 2017-06-13 |
| Returned To Mfg | 2017-06-14 |
| Catalog Number | 2040LC |
| Lot Number | L16702040 |
| ID Number | 25GA X 5MM |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Age | 1 DY |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEMED SYSTEMS INC. |
| Manufacturer Address | 8 KANE INDUSTRIAL DRIVE HUDSON MA 01749 US 01749 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-06-13 |