MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,05 report with the FDA on 2011-02-18 for RENU MULTIPLUS MULTI-PURPOSE SOLUTION manufactured by Bausch & Lomb.
[1711497]
Pt's mother reported son was diagnosed with a bacterial infection in both eyes. F/u with the treating doctor confirmed the pt was diagnosed with bilateral central and infectious corneal ulcers and treated with tobradex for ten days. No cultures were performed. Pt recovered with multiple corneal scars. Doctor related event to contact lens abuse and overwear.
Patient Sequence No: 1, Text Type: D, B5
[8836693]
The product was returned and eval results found the solution met all chemical specifications. Medical documentation does not relate event to the product but rather to abuse and overwear of the contact lenses. Pt wore same pair of lenses for one yr and slept with the lenses. The type of lenses worn is unk. Based on all info, no causal factor can be determined and no conclusion can be drawn.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1313525-2011-00002 |
| MDR Report Key | 2001638 |
| Report Source | 04,05 |
| Date Received | 2011-02-18 |
| Date of Report | 2011-02-09 |
| Date of Event | 2010-12-17 |
| Date Mfgr Received | 2011-02-09 |
| Device Manufacturer Date | 2010-02-01 |
| Date Added to Maude | 2011-03-01 |
| 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 | TES 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 RD |
| 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 | RENU MULTIPLUS MULTI-PURPOSE SOLUTION |
| Product Code | LYL |
| Date Received | 2011-02-18 |
| Returned To Mfg | 2011-01-24 |
| Lot Number | GB0043 |
| Device Expiration Date | 2012-02-29 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2011-02-18 |