MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2010-08-25 for SCHEIN STERILE LUBRICATING JELLY 4 OZ. TUBE manufactured by Triad Group, Inc..
[16421944]
When using schein sterile lubricating jelly, 4 oz. Tube, lot 9b121, over 30 pts complained of vaginal irritation. All pts were prescribed a medicated ointment. Upon using the prescribed medicated ointment, the symptoms have resolved.
Patient Sequence No: 1, Text Type: N, H10
[16708366]
When using schein sterile lubricating jelly, 4 oz. Tube, lot 9b121, over 30 pts complained of vaginal irritation. All pts were prescribed a medicated ointment.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2128643-2010-00001 |
| MDR Report Key | 1819564 |
| Report Source | 05 |
| Date Received | 2010-08-25 |
| Date of Report | 2010-08-25 |
| Date of Event | 2010-02-09 |
| Date Mfgr Received | 2010-02-09 |
| Device Manufacturer Date | 2009-02-06 |
| Date Added to Maude | 2012-03-02 |
| 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 | ALLISON STRAY |
| Manufacturer Street | 700 WEST NORTH SHORE DRIVE |
| Manufacturer City | HARTLAND WI 53029 |
| Manufacturer Country | US |
| Manufacturer Postal | 53029 |
| Manufacturer Phone | 2625382900 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SCHEIN STERILE LUBRICATING JELLY 4 OZ. TUBE |
| Generic Name | LUBRICATING JELLY |
| Product Code | FHX |
| Date Received | 2010-08-25 |
| Returned To Mfg | 2010-03-04 |
| Lot Number | 9B121 |
| Device Expiration Date | 2012-02-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TRIAD GROUP, INC. |
| Manufacturer Address | HARTLAND WI US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-08-25 |