MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2013-01-07 for BALANCED SALT SOLUTION ENDOSOL manufactured by Abbott Medical Optics.
[3106915]
We received a report that a bottle of balanced salt solution fell to the floor after the hanger failed during a surgical procedure. There was no injury to the patient or the doctor.
Patient Sequence No: 1, Text Type: D, B5
[10467961]
(b)(6). All pertinent information available to the manufacturer has been submitted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9614546-2013-00002 |
| MDR Report Key | 2898216 |
| Report Source | 01,05,06 |
| Date Received | 2013-01-07 |
| Date of Report | 2012-12-20 |
| Date of Event | 2012-10-18 |
| Date Mfgr Received | 2012-12-20 |
| Device Manufacturer Date | 2012-06-16 |
| Date Added to Maude | 2013-01-07 |
| 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 | MS. STEPHANIE SOLOMON |
| Manufacturer Street | ABBOTT MEDICAL OPTICS INC. 1700 EAST ST. ANDREW PLACE |
| Manufacturer City | SANTA ANA CA 92705 |
| Manufacturer Country | US |
| Manufacturer Postal | 92705 |
| Manufacturer Phone | 7145663731 |
| Manufacturer Street | AMO GRONIGEN VAN SWIETENLAAN 5 |
| Manufacturer City | GRONINGEN 9728NX |
| Manufacturer Country | NL |
| Manufacturer Postal Code | 9728 NX |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BALANCED SALT SOLUTION |
| Generic Name | SURGICAL ADJUNCTS |
| Product Code | KIP |
| Date Received | 2013-01-07 |
| Model Number | ENDOSOL |
| Catalog Number | BALANCED SALT SOLUTION |
| Lot Number | 12G1604 |
| Device Expiration Date | 2014-06-30 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT MEDICAL OPTICS |
| Manufacturer Address | SANTA ANA CA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-01-07 |