MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-03-19 for VUMORE SPECULUM 6106 manufactured by Medical Engineering Co..
[29261]
Medical engineering corp. 2317 eaton lane, racine, wi 53404. This product was never mfg by the cooper surgical subsidiary purchased by medical engineering corp, nor was it ever mfg by medical engineering corp.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1008675 |
| MDR Report Key | 31325 |
| Date Received | 1996-03-19 |
| Date of Report | 1996-03-13 |
| Date of Event | 1996-01-31 |
| Date Added to Maude | 1996-03-21 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VUMORE SPECULUM |
| Generic Name | SPECULUM |
| Product Code | HDG |
| Date Received | 1996-03-19 |
| Model Number | 6106 |
| Operator | OTHER |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 32396 |
| Manufacturer | MEDICAL ENGINEERING CO. |
| Manufacturer Address | 2317 EATON LANE RACINE WI 53404 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 1996-03-19 |