MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2007-02-09 for SURGILUBE 0168-0205-43 manufactured by Altana Inc..
[18307409]
Pt experienced burning sensation in vaginal area.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2432435-2006-00001 |
| MDR Report Key | 3359488 |
| Report Source | 04 |
| Date Received | 2007-02-09 |
| Date of Report | 2006-11-20 |
| Date of Event | 2006-09-05 |
| Date Added to Maude | 2013-09-23 |
| 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 Street | 60 BAYLIS RD. P.O. BOX 2006 |
| Manufacturer City | MELVILLE NY 11747 |
| Manufacturer Country | US |
| Manufacturer Postal | 11747 |
| Manufacturer Phone | 6314547677 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SURGILUBE |
| Generic Name | SURGILUBE LUBRICANT |
| Product Code | KMJ |
| Date Received | 2007-02-09 |
| Model Number | 0168-0205-43 |
| Catalog Number | 0168-0205-43 |
| Lot Number | T324 |
| Device Expiration Date | 2009-08-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALTANA INC. |
| Manufacturer Address | MELVILLE NY US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2007-02-09 |