MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2011-08-18 for STORZ ANTERIOR CHAMBER NEEDLE 27GA E7106 manufactured by Bausch & Lomb, Inc..
[2200388]
A report from the user facility states that during preparation for the procedure the 27 gauge needle tip "flew across the room" after being attached. There was no pt contact and no report of injury to personnel.
Patient Sequence No: 1, Text Type: D, B5
[9475446]
The product is not available for eval.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1920664-2011-00108 |
| MDR Report Key | 2255207 |
| Report Source | 06 |
| Date Received | 2011-08-18 |
| Date of Report | 2011-08-12 |
| Date of Event | 2011-08-11 |
| Date Mfgr Received | 2011-08-12 |
| Date Added to Maude | 2011-11-02 |
| 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 | SHARON TRELFORD, DIR |
| Manufacturer Street | 30 ENTERPRISE, STE. 450 |
| Manufacturer City | ALISO VIEJO CA 92656 |
| Manufacturer Country | US |
| Manufacturer Postal | 92656 |
| Manufacturer Phone | 9493891786 |
| Manufacturer Street | 3365 TREE CT. INDUSTRIAL BLVD. |
| Manufacturer City | ST. LOUIS MO 63122669 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 63122 6694 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STORZ ANTERIOR CHAMBER NEEDLE 27GA |
| Generic Name | 27 GAUGE ANGLE TIP NEEDLE |
| Product Code | HNM |
| Date Received | 2011-08-18 |
| Model Number | E7106 |
| Catalog Number | E7106 |
| Lot Number | M517410 |
| Device Expiration Date | 2015-10-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAUSCH & LOMB, INC. |
| Manufacturer Address | ROCHESTER NY US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-08-18 |