MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06 report with the FDA on 2014-07-21 for VITAL VUE EXT YANK W/EXT 12FR METAL SUCT 8886828206 manufactured by Covidien, Formerly Nellcor Puritan Bennett Mexico, S.a. De C.
[21332566]
Procedure: dental. According to the reporter: a metal object fell into pts mouth during bimaxillary osteotomy. No injury to pt.
Patient Sequence No: 1, Text Type: D, B5
[21601975]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9610849-2014-00007 |
| MDR Report Key | 4528168 |
| Report Source | 01,06 |
| Date Received | 2014-07-21 |
| Date of Report | 2014-07-02 |
| Date of Event | 2014-06-26 |
| Date Mfgr Received | 2014-07-02 |
| Date Added to Maude | 2015-03-16 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | SHARON MURPHY, QA |
| Manufacturer Street | 60 MIDDLETOWN AVE. |
| Manufacturer City | NORTH HAVEN CT 06473 |
| Manufacturer Country | US |
| Manufacturer Postal | 06473 |
| Manufacturer Phone | 2034925267 |
| Manufacturer G1 | COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT MEXICO, S.A. DE C |
| Manufacturer Street | 37 BLVD. INSURGENTES, |
| Manufacturer City | TIJUANA, B.C. 22225 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 22225 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VITAL VUE EXT YANK W/EXT 12FR METAL SUCT |
| Generic Name | SINGLE USE LAPAROSCOPIC HAND INSTRU |
| Product Code | HBI |
| Date Received | 2014-07-21 |
| Catalog Number | 8886828206 |
| Lot Number | 122560058 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT MEXICO, S.A. DE C |
| Manufacturer Address | 37 BLVD. INSURGENTES, TIJUANA, B.C. 22225 MX 22225 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-07-21 |