MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-08-15 for SURGILUBE 68020555 manufactured by Altana, Inc..
[39981751]
Actual device in event was evaluated. Chemical tests were performed, both descriptive and assay. Both the product that was returned and the retain samples were tested and found all products to be within specification. Manufacturing and quality assurance records for lot #p541 have been reviewed and confirm satisfactory checks and controls were performed during the production of this batch.
Patient Sequence No: 1, Text Type: N, H10
[39981752]
On (b)(6) 2005 - patient was given a vaginal examination using surgilube, 5 grams. Patient experienced burning sensation in vaginal area.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2432435-2005-00002 |
| MDR Report Key | 5483340 |
| Date Received | 2005-08-15 |
| Date of Report | 2005-06-20 |
| Date of Event | 2005-06-11 |
| Date Mfgr Received | 2005-06-14 |
| Date Added to Maude | 2016-03-07 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Street | 60 BAYLIS RD. |
| Manufacturer City | MELVILLE NY 11747 |
| Manufacturer Country | US |
| Manufacturer Postal | 11747 |
| Manufacturer Phone | 6314547677 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | SURGILUBE |
| Generic Name | STERILE LUBRICANT |
| Product Code | KMJ |
| Date Received | 2005-08-15 |
| Returned To Mfg | 2005-06-17 |
| Catalog Number | 68020555 |
| Lot Number | P541 |
| Device Expiration Date | 2005-08-05 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALTANA, INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2005-08-15 |