MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,04 report with the FDA on 2011-10-19 for RENU MULTIPLUS MULTI-PURPOSE SOLUTION manufactured by Bausch & Lomb.
[2295257]
Retailer reported that a consumer experienced burning/stinging after product use. This complaint is reported against a product lot that is being recalled due to an incorrect expiration date and lot code listing on the outer carton. The complaint is not related to the recall.
Patient Sequence No: 1, Text Type: D, B5
[9376111]
This issue was discovered during the investigation of an inventory discrepancy. The investigation revealed that one pallet of bulk product bottles was incorrectly cartooned. This is not a health hazard concern as the product is cartooned with the appropriate content of labeling and it has a well established stability profile past the two year expiration date.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1313525-2011-00019 |
| MDR Report Key | 2327384 |
| Report Source | 00,04 |
| Date Received | 2011-10-19 |
| Date of Report | 2011-09-27 |
| Date Mfgr Received | 2011-09-27 |
| Device Manufacturer Date | 2011-03-01 |
| Date Added to Maude | 2011-12-20 |
| 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 | Z3042-2011 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RENU MULTIPLUS MULTI-PURPOSE SOLUTION |
| Product Code | LYL |
| Date Received | 2011-10-19 |
| Lot Number | GC1107 |
| Device Expiration Date | 2013-03-31 |
| 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 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-10-19 |