MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,01,05 report with the FDA on 2015-05-15 for BIOTRUE MULTI-PURPOSE SOLUTION manufactured by Bausch + Lomb.
[19818226]
A poison control center reported a (b)(6) child accidentally drank 60 ml of biotrue multi-purpose solution. The child did not exhibit any symptoms but was hospitalized to monitor his clinical status due to possible toxicity of boron. The child was given a forced hydration. The hospital indicated the dosage of boron serum was below the toxicity limit. The child was discharged from the hospital two days later.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1313525-2015-01497 |
| MDR Report Key | 4780290 |
| Report Source | 00,01,05 |
| Date Received | 2015-05-15 |
| Date of Report | 2015-05-09 |
| Date of Event | 2015-05-09 |
| Date Mfgr Received | 2015-05-09 |
| Date Added to Maude | 2015-05-20 |
| 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 Street | 1400 NORTH GOODMAN STREET |
| Manufacturer City | ROCHESTER NY 14609 |
| Manufacturer Country | US |
| Manufacturer Postal | 14609 |
| Manufacturer Phone | 5853385091 |
| Manufacturer G1 | BAUSCH + LOMB |
| Manufacturer Street | 8507 PELHAM ROAD |
| Manufacturer City | GREENVILLE NC 29615959 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 29615 9598 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BIOTRUE MULTI-PURPOSE SOLUTION |
| Generic Name | ACCESSORIES, SOLUTION, CLEANERS |
| Product Code | LYL |
| Date Received | 2015-05-15 |
| 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 | 1. Hospitalization | 2015-05-15 |