MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,other report with the FDA on 2018-12-20 for BIOTRUE MULTI-PURPOSE SOLUTION(MILAN) manufactured by Bausch & Lomb Incorporated.
[131085922]
The product has not been returned and no additional information has been received. A review of the lot manufacturing records is in progress. Based on all available information, no causal factors can be determined and no conclusion can be drawn.
Patient Sequence No: 1, Text Type: N, H10
[131085923]
It was reported by (b)(6) that a consumer suffered an infection after applying the product which resulted in the consumer being hospitalized. It was also reported that (b)(6) obtained the product for their testing and the results did not comply with iso 14729:2001. Further medical information surrounding the adverse event was requested as well as information on the product that was tested. Additional information has not been received.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001313525-2018-00242 |
| MDR Report Key | 8186300 |
| Report Source | FOREIGN,OTHER |
| Date Received | 2018-12-20 |
| Date of Report | 2018-12-11 |
| Device Manufacturer Date | 2017-05-16 |
| Date Added to Maude | 2018-12-20 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. JENNIFER GAMET |
| Manufacturer Street | 1400 NORTH GOODMAN STREET |
| Manufacturer City | ROCHESTER NY 14609 |
| Manufacturer Country | US |
| Manufacturer Postal | 14609 |
| Manufacturer Phone | 5853386853 |
| Manufacturer G1 | BAUSCH + LOMB-IOM S.P.A |
| Manufacturer Street | VIA PASUBIO 34 20050 MACHERIO |
| Manufacturer City | MILAN 20846 |
| Manufacturer Country | IT |
| Manufacturer Postal Code | 20846 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BIOTRUE MULTI-PURPOSE SOLUTION(MILAN) |
| Generic Name | ACCESSORIES, SOLUTION, CLEANERS FOR LENSES |
| Product Code | LYL |
| Date Received | 2018-12-20 |
| Lot Number | MC1605 |
| Device Expiration Date | 2019-05-31 |
| 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 INCORPORATED |
| Manufacturer Address | 1400 NORTH GOODMAN STREET ROCHESTER NY 14609 US 14609 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2018-12-20 |