MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2008-08-13 for SURGILUBE manufactured by Altana, Inc..
[18975589]
Patient was seen by dr. (b)(6)'s office at(b)(6) medical clinic-internal medicine department, phone# (b)(6). Patient states she had an allergic reaction after doctor used surgilube during her exam for a pap smear. Patient claims she started to develop vaginal blisters and went to the emergency room at (b)(6) medical center-emergency dept. , phone# (b)(6). The attending physician: (b)(6) , m. D. Facep (who is no longer with the hospital). (b)(6) 2004, they treated her for vulvar contact dermatitis and prescribed sulfadine for the vaginal blisters. (b)(6) 2004 at 10:20 am, she had a follow-up appt. With dr. (b)(6) on and after examining her stated she now had a yeast infection and prescribed monistat 7. Complaint sample is not available as the foil pac was discarded.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2432435-2008-00001 |
| MDR Report Key | 2518132 |
| Report Source | 04 |
| Date Received | 2008-08-13 |
| Date of Report | 2004-05-11 |
| Date of Event | 2004-04-22 |
| Date Mfgr Received | 2004-05-07 |
| Date Added to Maude | 2012-04-06 |
| 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 | NONE |
| Product Code | KMJ |
| Date Received | 2008-08-13 |
| Model Number | NA |
| Catalog Number | NA |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALTANA, INC. |
| Manufacturer Address | MELVILLE NY 11747 US 11747 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2008-08-13 |