MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 1997-03-17 for STORZ LEIVERS MOUTH GAG FRAME, CHILD SIZE N7537 L manufactured by Storz Instrument Co..
[20519288]
This mouth gag broke during a tonsillectomy procedure. The physician present during the procedure examined the pt and indicated that there were no pt problems as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1932180-1997-00032 |
| MDR Report Key | 77256 |
| Report Source | 06 |
| Date Received | 1997-03-17 |
| Date of Report | 1997-02-13 |
| Date of Event | 1997-02-11 |
| Date Facility Aware | 1997-02-11 |
| Report Date | 1997-02-13 |
| Date Reported to Mfgr | 1997-02-13 |
| Date Mfgr Received | 1997-02-13 |
| Date Added to Maude | 1997-03-21 |
| 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 | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STORZ LEIVERS MOUTH GAG FRAME, CHILD SIZE |
| Generic Name | MOUTH GAG |
| Product Code | KBN |
| Date Received | 1997-03-17 |
| Model Number | NA |
| Catalog Number | N7537 L |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | UNKNOWN |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 76969 |
| Manufacturer | STORZ INSTRUMENT CO. |
| Manufacturer Address | 3365 TREE CT INDUSTRIAL BLVD ST LOUIS MO 63122 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1997-03-17 |