MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-05-13 for VISITOR SPECTACLE 18213 manufactured by Ammerican Allsafe Co..
[8553]
Ear piece on glasses will not stay attached. This has also been encountered with other spectacules rptr has received.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1001966 |
| MDR Report Key | 13227 |
| Date Received | 1994-05-13 |
| Date of Event | 1994-04-22 |
| Date Added to Maude | 1994-05-16 |
| 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 |
| Reporter Occupation | PHARMACIST |
| 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 | VISITOR SPECTACLE |
| Product Code | HQY |
| Date Received | 1994-05-13 |
| Model Number | 18213 |
| Device Availability | N |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 13225 |
| Manufacturer | AMMERICAN ALLSAFE CO. |
| Manufacturer Address | TONAWANDA NY 14150 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1994-05-13 |