MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2010-12-20 for RENU MULTIPLUS MULTI-PURPOSE SOLUTION manufactured by Bausch + Lomb.
[18611581]
(b)(6) fda reported to bausch + lomb that a modified bioburden test was performed on one sample from lot gh0066 and resulted in an observation of viable mold. This reported result indicates the potential for compromised package sterility. The mold species was not identified and a bausch + lomb investigation is ongoing.
Patient Sequence No: 1, Text Type: D, B5
[18685865]
Product was not returned for eval. A review of the lot batch records and chemical testing of the retain sample showed all requirements were met.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1313525-2010-00027 |
| MDR Report Key | 1937614 |
| Report Source | 00 |
| Date Received | 2010-12-20 |
| Date of Report | 2010-12-06 |
| Date Mfgr Received | 2010-12-06 |
| Device Manufacturer Date | 2010-08-01 |
| Date Added to Maude | 2011-03-02 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| 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 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Removal Correction Number | PENDING |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RENU MULTIPLUS MULTI-PURPOSE SOLUTION |
| Product Code | LYL |
| Date Received | 2010-12-20 |
| Lot Number | GH0066 |
| Device Expiration Date | 2012-08-31 |
| Operator | OTHER |
| 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 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-12-20 |