MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2011-02-23 for RENU MULTIPLUS MULTI-PURPOSE SOLUTION manufactured by Bausch + Lomb.
[17473368]
Consumer reported burning and stinging after use of the solution. The solution expired in march 2008. Icp mass spectrometry was performed on another sample of this lot and showed a higher than expected amount of trace iron in the bottle of solution. The source of the iron was identified as one particular lot of one of the raw materials, poloxamine. The product involved is expired and a global recall was completed in 2007 for this lot.
Patient Sequence No: 1, Text Type: D, B5
[17649396]
Icp mass spectrometry was performed on another sample of this lot and showed a higher than expected amount of trace iron in the bottle of solution. The source of the iron was identified as one particular lot of one of the raw materials, poloxamine. A global recall was completed in 2007 for this lot.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1313525-2011-00003 |
| MDR Report Key | 2035249 |
| Report Source | 04 |
| Date Received | 2011-02-23 |
| Date of Report | 2010-12-13 |
| Date Mfgr Received | 2010-12-13 |
| Device Manufacturer Date | 2006-03-01 |
| Date Added to Maude | 2011-04-06 |
| 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 ROAD |
| Manufacturer City | GREENVILLE SC 29615 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 29615 |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Removal Correction Number | Z-0715-2007 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RENU MULTIPLUS MULTI-PURPOSE SOLUTION |
| Product Code | LYL |
| Date Received | 2011-02-23 |
| Lot Number | GC6037 |
| Device Expiration Date | 2008-03-31 |
| 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 | 2011-02-23 |