MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-08-10 for BOSTON IV manufactured by Bausch & Lomb Incorporated.
[82456480]
Further product details, event and medical information were requested but have not been received. The product was not returned for evaluation and the lot number is not known. Based on available information, no causal factors can be determined and no conclusion can be drawn.
Patient Sequence No: 1, Text Type: N, H10
[82456481]
An optician reported a patient visited a hospital and was treated for a corneal ulcer. The optician does not know which eye was affected. Further product details, event and medical information were requested but have not been received.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001313525-2017-02706 |
| MDR Report Key | 6786469 |
| Date Received | 2017-08-10 |
| Date of Report | 2017-07-10 |
| Date of Event | 2017-07-10 |
| Date Mfgr Received | 2017-07-10 |
| Date Added to Maude | 2017-08-10 |
| 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. TES PROUD |
| Manufacturer Street | 1400 NORTH GOODMAN STREET |
| Manufacturer City | ROCHESTER NY 14609 |
| Manufacturer Country | US |
| Manufacturer Postal | 14609 |
| Manufacturer Phone | 5853388549 |
| Manufacturer G1 | BAUSCH & LOMB WILMINGTON |
| Manufacturer Street | 100 RESEARCH DRIVE |
| Manufacturer City | WILMINGTON MA 01887 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 01887 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | BOSTON IV |
| Generic Name | LENS, CONTACT (OTHER MATERIAL) - DAILY |
| Product Code | HQD |
| Date Received | 2017-08-10 |
| ID Number | NI |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| 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. Required No Informationntervention | 2017-08-10 |