MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-09-17 for SKLAR INSTRUMENTS PEDERSN, LARGE, BLUE 91-5046 manufactured by Sklar Instruments.
[84677]
Additional info received from mfr on 10/08/1997: the device has not previously been noted in any investigable complaint or mdr. The device is three years in service, consequently any initial defect would have been noted previously. The wear mentioned is possibly the result of mishandling, that is inappropriate contact with solid objects or surfaces possibly during sterilization or storage.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 120762 |
| MDR Report Key | 120762 |
| Date Received | 1997-09-17 |
| Date of Report | 1997-09-17 |
| Date of Event | 1997-09-11 |
| Date Facility Aware | 1997-09-11 |
| Report Date | 1997-09-17 |
| Date Added to Maude | 1997-09-19 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SKLAR INSTRUMENTS |
| Generic Name | VAGINAL SPECULUM |
| Product Code | HDF |
| Date Received | 1997-09-17 |
| Returned To Mfg | 1997-09-17 |
| Model Number | PEDERSN, LARGE, BLUE |
| Catalog Number | 91-5046 |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 3 YR |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 118385 |
| Manufacturer | SKLAR INSTRUMENTS |
| Manufacturer Address | 889 S MATLACK ST WEST CHESTER PA 19382 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 1 | 1. Required No Informationntervention | 1997-09-17 |