MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-05-31 for 0036560 manufactured by Conmed Corporation.
[76285731]
Patient Sequence No: 1, Text Type: N, H10
[76285732]
A foreign matter was discovered inside of the tubing when the package was opened. It was not used on a patient. Manufacturer response for suction connection tubing, (brand not provided) (per site reporter): i am waiting for a shipping label to send the tubing back. Stay tuned.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6600525 |
| MDR Report Key | 6600525 |
| Date Received | 2017-05-31 |
| Date of Report | 2017-05-25 |
| Date of Event | 2017-05-24 |
| Report Date | 2017-05-25 |
| Date Reported to FDA | 2017-05-25 |
| Date Reported to Mfgr | 2017-05-25 |
| Date Added to Maude | 2017-05-31 |
| 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 |
| Generic Name | SUCTION SYSTEM TUBING, (ASPIRATING TUBING) |
| Product Code | BYY |
| Date Received | 2017-05-31 |
| Model Number | 0036560 |
| Catalog Number | 0036560 |
| Lot Number | 201703245 |
| Device Availability | Y |
| Device Age | 1 DY |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CONMED CORPORATION |
| Manufacturer Address | 525 FRENCH RD. UTICA NY 13502 US 13502 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-05-31 |