MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2011-11-18 for BIOTRUE MULTI-PURPOSE SOLUTION manufactured by Bausch & Lomb.
[2313774]
Doctor reported a pt was diagnosed with a corneal abrasion in the left eye. Doctor treated pt for six weeks. At a follow up visit, doctor diagnosed acanthamoeba keratitis and referred pt to the (b)(6) for further treatment. No culture was performed by the reporting doctor. Pt did not keep follow up appointment. Doctor provided pt's name and telephone number. Attempts were made to contact the pt for additional information and return of product but there has been no response.
Patient Sequence No: 1, Text Type: D, B5
[9495744]
The device was not returned for evaluation and the lot number information is unknown. Doctor does not relate event to a specific product, etiology is unknown. Based on all information, no causal factors can be determined and no conclusion can be drawn.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1313525-2011-00021 |
| MDR Report Key | 2350577 |
| Report Source | 05 |
| Date Received | 2011-11-18 |
| Date of Report | 2011-10-24 |
| Date of Event | 2011-09-10 |
| Date Mfgr Received | 2011-10-24 |
| Date Added to Maude | 2011-11-30 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | TESS PROUD |
| Manufacturer Street | 1400 NORTH GOODMAN ST. |
| Manufacturer City | ROCHESTER NY 14609 |
| Manufacturer Country | US |
| Manufacturer Postal | 14609 |
| Manufacturer Phone | 5853388549 |
| Manufacturer G1 | BAUSCH & LOMB |
| Manufacturer Street | 8507 PELHAM ROAD |
| Manufacturer City | GREENVILLE SC 29615 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 29615 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BIOTRUE MULTI-PURPOSE SOLUTION |
| Product Code | LYL |
| Date Received | 2011-11-18 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAUSCH & LOMB |
| Manufacturer Address | ROCHESTER NY 14609 US 14609 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2011-11-18 |