MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,05 report with the FDA on 2011-07-08 for BIOTRUE MULTI-PURPOSE SOLUTION manufactured by Bausch & Lomb.
[2121597]
Patient reported eyes burning after product use and continued using product for three days. A pharmacist instructed patient to discontinue the product and use refresh plus. About 24 hours later, patient experienced hives in throat, hands, and feet. A few days later, patient's condition did not resolve and visited a hospital emergency room. The emergency room doctor administered a shot of benadryl and rx for vistaril. Patient felt she had a reaction to the vistaril and visited another hospital emergency room a few days later. Patient confirmed condition resolved. The optician reported that the patient also used the multi-purpose solution as a rewetting drop. His opinion was that the reaction is unlikely related to the product as an allergic reaction is immediate rather than delayed 24 hours. Medical records from the first hospital noted patient presented with "burning pain all over". No fever, chills, trauma, nor rash were present. Patient thought she had reaction to something she ate four days ago. Impression was paresthesias and diffuse tenderness. Medical records from second hospital noted neuropathy and that patient did not have allergic reaction but rather acute exacerbation of diffuse pain.
Patient Sequence No: 1, Text Type: D, B5
[9193911]
The product was not returned for evaluation. The lot number information is unknown. Medical documentation received does not relate event to a specific product. Based on all information, no causal factors can be determined and no conclusion can be drawn.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1313525-2011-00012 |
| MDR Report Key | 2161168 |
| Report Source | 04,05 |
| Date Received | 2011-07-08 |
| Date of Report | 2011-06-14 |
| Date of Event | 2011-04-26 |
| Date Mfgr Received | 2011-06-14 |
| Date Added to Maude | 2011-07-15 |
| 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 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BIOTRUE MULTI-PURPOSE SOLUTION |
| Product Code | LYL |
| Date Received | 2011-07-08 |
| 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. Required No Informationntervention | 2011-07-08 |