MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 1997-12-01 for LIEVERS MOUTH GAG N7536 L manufactured by Storz Instrument Co..
[7774452]
Evaluation of the instrument by the manufacturer's rep found it to be in satisfactory condition. The instrument did not show any signs of misuse and only a little sign of rust on the thumbplate. At the point of breakage there appeared to be a "weld". It could not be determined if this weld was done in mfg or at a later date. It appeared as if this weld just broke as the result of normal wear and tear. The instrument was at least four years old. The number of times used was not known.
Patient Sequence No: 1, Text Type: N, H10
[20888125]
This mouth gag was being used during a procedure to repair a chronic sinusitis condition. While the physician was securing the mouth gag, the side bar of the mouth gag broke away from the main apparatus lacerating the pt's left lip, requiring sutures. A plastic surgeon is being consulted concerning the scarring that has occurred.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1932180-1997-00106 |
| MDR Report Key | 135373 |
| Report Source | 06 |
| Date Received | 1997-12-01 |
| Date of Report | 1997-10-27 |
| Date of Event | 1997-06-26 |
| Date Facility Aware | 1997-06-26 |
| Report Date | 1997-10-27 |
| Date Reported to Mfgr | 1997-10-27 |
| Date Mfgr Received | 1997-10-27 |
| Date Added to Maude | 1997-12-03 |
| 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 | LIEVERS MOUTH GAG |
| Generic Name | MOUTH GAG |
| Product Code | KBN |
| Date Received | 1997-12-01 |
| Model Number | NA |
| Catalog Number | N7536 L |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | UNKNOWN |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 132262 |
| Manufacturer | STORZ INSTRUMENT CO. |
| Manufacturer Address | 499 SOVEREIGN CT. ST. LOUIS MO 63011 US |
| Baseline Brand Name | FRA MOUTH GAG LEIVR CHILD SIZE LT |
| Baseline Generic Name | MOUTH GAG |
| Baseline Model No | NA |
| Baseline Catalog No | N7536 L |
| Baseline ID | NA |
| Baseline Device Family | MOUTH GAG |
| Baseline Shelf Life Contained | A |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | Y |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1997-12-01 |