MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-11-17 for SMITH SUNGLASSES manufactured by Nakanishi, Inc..
[17764112]
Female person was wearing sunglasses while playing football in the fall of 1993. She states she fell while running and landed on her side. Her husband states she landed on her face. She cut her eyebrow in the fall and needed 15 stitches. She does not know exactly what happened, but afterward noticed that the left earpiece came out of the frame. She did not notify co sooner because she did not have address.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3022808-1995-00001 |
| MDR Report Key | 28750 |
| Date Received | 1995-11-17 |
| Date of Report | 1995-11-15 |
| Date of Event | 1993-01-01 |
| Date Facility Aware | 1995-11-06 |
| Report Date | 1995-11-17 |
| Date Added to Maude | 1995-12-18 |
| Event Key | 0 |
| Report Source Code | Distributor 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 | SMITH SUNGLASSES |
| Generic Name | SUNGLASSES |
| Product Code | HQY |
| Date Received | 1995-11-17 |
| Returned To Mfg | 1995-11-06 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 3 YR |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 29711 |
| Manufacturer | NAKANISHI, INC. |
| Manufacturer Address | NO 1 OSAKA EKIMAE BLDG 3-1-1000 UMEDA, 1-CHOME KUTA-KU, OSAKA JA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1995-11-17 |