MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 1997-08-29 for SCS SCREWDRIVER SHORT HANDLE 046.066 manufactured by Institut Straumann Ag.
[90891]
The clinician reports that the pt swallowed a scs screwdriver insert. The pt went to the hospital for a chest x-ray. The x-ray was negative.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1222315-1997-00295 |
| MDR Report Key | 117098 |
| Report Source | 05 |
| Date Received | 1997-08-29 |
| Date of Report | 1997-08-25 |
| Date of Event | 1997-07-24 |
| Date Mfgr Received | 1997-08-25 |
| Date Added to Maude | 1997-09-04 |
| 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 |
| Reporter Occupation | DENTIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SCS SCREWDRIVER SHORT HANDLE |
| Generic Name | INSTRUMENT |
| Product Code | EJB |
| Date Received | 1997-08-29 |
| Returned To Mfg | 1997-08-29 |
| Model Number | NA |
| Catalog Number | 046.066 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 114848 |
| Manufacturer | INSTITUT STRAUMANN AG |
| Manufacturer Address | HAUPTSTRASSE 26D WALDENBURG SZ CH-4437 |
| Baseline Brand Name | SCS SCREWDRIVER HANDLE, SHORT |
| Baseline Generic Name | DENTAL HAND INSTRUMENT |
| Baseline Model No | NA |
| Baseline Catalog No | 046.066 |
| Baseline ID | NA |
| Baseline Device Family | SCS SCREWDRIVER |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K894844 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1997-08-29 |