MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2009-04-03 for VITAL VUE EXT YANKAUER SUCTION W/BULB TP 8886828006 manufactured by Tijuana - Uss.
[1065982]
According to the reporter: prostate procedure. The device was covered and mistakenly left on the patient's thigh during surgery. After a while, the patient sustained a burn from the device. The burn was noted when the device was taken off the patient's thigh. No information about burn treatment was provided. Efforts have been made to obtain additional information. No further details have been provided.
Patient Sequence No: 1, Text Type: D, B5
[8223054]
.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9610849-2009-00005 |
| MDR Report Key | 1356376 |
| Report Source | 05 |
| Date Received | 2009-04-03 |
| Date of Report | 2009-03-23 |
| Date of Event | 2009-03-17 |
| Date Mfgr Received | 2009-03-23 |
| Date Added to Maude | 2009-04-09 |
| 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 | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | TERRY CALLAHAN |
| Manufacturer Street | 60 MIDDLETOWN AVE. |
| Manufacturer City | NORTH HAVEN CT 06473 |
| Manufacturer Country | US |
| Manufacturer Postal | 06473 |
| Manufacturer Phone | 2034926273 |
| Manufacturer G1 | TIJUANA - USS |
| Manufacturer Street | 1855 A DORNOCH CT. |
| Manufacturer City | TIJUANA SAN DIEGO CA 92173 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92173 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VITAL VUE EXT YANKAUER SUCTION W/BULB TP |
| Generic Name | NONE |
| Product Code | HBI |
| Date Received | 2009-04-03 |
| Catalog Number | 8886828006 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TIJUANA - USS |
| Manufacturer Address | 1855 A. DORNOCH CT. TIJUANA SAN DIEGO CA 92173 US 92173 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2009-04-03 |