MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,05 report with the FDA on 1997-12-04 for SUN CLOUD DOCINI 42660570 manufactured by Bausch & Lomb, Inc..
[77745]
Consumer alleges an inquiry requiring medical treatment, caused by her sunglasses when she fell on her face while bicycling.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1643383-1997-00010 |
| MDR Report Key | 136812 |
| Report Source | 04,05 |
| Date Received | 1997-12-04 |
| Date of Report | 1997-11-28 |
| Date of Event | 1997-08-31 |
| Date Mfgr Received | 1997-09-29 |
| Date Added to Maude | 1997-12-10 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 | 0 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SUN CLOUD |
| Generic Name | SUNGLASS |
| Product Code | HQY |
| Date Received | 1997-12-04 |
| Returned To Mfg | 1997-09-29 |
| Model Number | DOCINI |
| Catalog Number | 42660570 |
| Lot Number | NA |
| ID Number | * |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | NA |
| Device Eval'ed by Mfgr | * |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 133647 |
| Manufacturer | BAUSCH & LOMB, INC. |
| Manufacturer Address | 5335 CASTROVILLE RD. SAN ANTONIO TX 78227 US |
| Baseline Brand Name | SUNCLOUD |
| Baseline Generic Name | SUNGLASSES |
| Baseline Model No | DOCINI |
| Baseline Catalog No | 42660570 |
| Baseline ID | NA |
| Baseline Device Family | NA |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | Y |
| Baseline Transitional | N |
| 510k Exempt | Y |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1997-12-04 |