MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-02-28 for BALANCED SALT SOLUTION ENDOSOL manufactured by Abbott Medical Optics.
[20743003]
Account reported the bottle fell from the i. V. Pole when the supporting strap broke as the phaco machine with i. V. Pole was being moved by a member of the o. R. Staff. Bottle struck the staff member on the head causing a mild concussion.
Patient Sequence No: 1, Text Type: D, B5
[20813105]
Without having the sample of the potential defective label it is not possible to perform an investigation apart from the formal batch review and retain samples verification. The review of the batch record did not reveal any deviation or non-conformity related to this complaint from all the checks carried out on the product during manufacturing process. No issues were found also from the review of the retained samples of the involved batch 10e0308. No other complaints were received for batch 10e0308 and no similar reports were received for this product. We are not able to definitively determine the cause of this event. All currently available information is included in this report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9614546-2011-00006 |
| MDR Report Key | 2002836 |
| Report Source | 05,06 |
| Date Received | 2011-02-28 |
| Date of Report | 2011-01-29 |
| Date Mfgr Received | 2011-01-29 |
| Date Added to Maude | 2011-02-28 |
| 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 | MRS. GRACE KROPIDLOWSKI |
| Manufacturer Street | 1700 EAST ST. ANDREW PLACE |
| Manufacturer City | SANTA ANA CA 92705 |
| Manufacturer Country | US |
| Manufacturer Postal | 92705 |
| Manufacturer Phone | 7142478200 |
| Manufacturer G1 | AMO GRONINGEN |
| Manufacturer Street | VAN SWIETENLAAN 5 |
| Manufacturer City | GRONINGEN, 9728NX |
| Manufacturer Country | NL |
| Manufacturer Postal Code | 9728 NX |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BALANCED SALT SOLUTION |
| Generic Name | BSS |
| Product Code | KIP |
| Date Received | 2011-02-28 |
| Model Number | ENDOSOL |
| Catalog Number | ENDOSOL |
| Lot Number | 10E0308 |
| Operator | NURSE |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT MEDICAL OPTICS |
| Manufacturer Address | 1700 EAST ST. ANDREW PLACE SANTA ANA CA 92705493 US 92705 4933 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2011-02-28 |