MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2011-04-06 for BAUSCH+LOMB RENU FRESH MULTI-PURPOSE SOLUTION manufactured by Bausch + Lomb.
[17959549]
The product was returned and evaluation results found the solution met chemical specifications. Pt has experienced similar reactions in the past with various products. Based on all info, no casual factor can be determined and no conclusion can be drawn.
Patient Sequence No: 1, Text Type: N, H10
[18042816]
Pt reported experiencing an anaphylactic shock after using a bottle of solution. Symptoms were dizziness, racing heartbeat, and fainting. Pt visited doctor who performed an ekg, blood tests, blood pressure, which all were abnormal. One hour later, pt's symptoms ceased and pt felt well again. There was no mediation prescribed. According to the pt, the doctor felt it was more of an allergic reaction than an anaphylactic shock. Pt has used product type before without any problems and was concerned that the formulation changed. Pt is allergic to benzyl alcohol. Pt also used new make up at the same time as the solution and feels the problem may lie with her new make up. Pt has experienced this type of reaction in the past with various products and one time when eyes were dilated by optician. Medical documentation has been requested but not received.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1313525-2011-00007 |
| MDR Report Key | 2064607 |
| Report Source | 04 |
| Date Received | 2011-04-06 |
| Date of Report | 2011-03-07 |
| Date of Event | 2011-03-07 |
| Date Mfgr Received | 2011-03-07 |
| Device Manufacturer Date | 2010-09-01 |
| Date Added to Maude | 2011-04-22 |
| 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 | BAUSCH+LOMB RENU FRESH MULTI-PURPOSE SOLUTION |
| Product Code | LYL |
| Date Received | 2011-04-06 |
| Returned To Mfg | 2011-03-24 |
| Lot Number | GH0125 |
| Device Expiration Date | 2012-08-31 |
| 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. Other | 2011-04-06 |