MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2006-02-10 for UNK * manufactured by *.
[476177]
It was reported on the medwatch form that a pt complained of tongue pain after surgery. Two areas of abrasions were observed on each side of the tongue secondary to the tongue clamp placement. No product catalogue number was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2430952-2006-00004 |
| MDR Report Key | 696367 |
| Report Source | 06 |
| Date Received | 2006-02-10 |
| Date of Report | 2006-02-10 |
| Date of Event | 2005-07-21 |
| Date Facility Aware | 2006-01-11 |
| Report Date | 2006-02-10 |
| Date Reported to FDA | 2006-02-10 |
| Date Added to Maude | 2006-04-07 |
| 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 | 0 |
| Manufacturer Contact | YANPING WANG |
| Manufacturer Street | 311C ENTERPRISE DR |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099362322 |
| Manufacturer G1 | J JAMNER SURGICAL INSTRUMENTS, INC |
| Manufacturer Street | 9 SKYLINE DR |
| Manufacturer City | HAWTHORNE NY 10532 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 10532 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNK |
| Generic Name | DAVIS MOUTH GAG WITH DAVIS RING MOUTH BL |
| Product Code | KBN |
| Date Received | 2006-02-10 |
| Model Number | * |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 685477 |
| Manufacturer | * |
| Manufacturer Address | * * * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-02-10 |