MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-09-12 for SMITH * SAPC3NSD manufactured by Bonedt.
[21716314]
On september 12, 1997 the distributor rec'd a letter from the complainant advising the dist. Of the injury. The complainant was wearing slider ab3 sunglasses while riding her mountain bike. She fell and hit her face on a rock. The nose piece broke off and she states it caused a cut requiring 20 stitches. The distributor believes the injury was caused by the person falling on her face and not by the dist's product.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3022808-1997-00003 |
| MDR Report Key | 119154 |
| Date Received | 1997-09-12 |
| Date of Report | 1997-09-12 |
| Date Facility Aware | 1997-09-12 |
| Report Date | 1997-09-12 |
| Date Added to Maude | 1997-09-15 |
| 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 |
| Generic Name | SUNGLASSES |
| Product Code | HQY |
| Date Received | 1997-09-12 |
| Model Number | * |
| Catalog Number | SAPC3NSD |
| Lot Number | * |
| ID Number | * |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | UNKNOWN |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 116822 |
| Manufacturer | BONEDT |
| Manufacturer Address | 29, RUE JJ ROUSSEAU OYONNAX (AIN) FR 01104 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1997-09-12 |