MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2009-08-26 for REPHRESH VAGINAL GEL manufactured by Lil Drug Store Products, Inc..
[2673558]
Consumer was in the early weeks of pregnancy when she used rephresh. She had a miscarriage at 6 weeks. She had been cramping from the start of pregnancy. She stated that after using the rephresh gel, only minutes later, she had a strange and uncomfortable feeling in her stomach. She stated further that something told her she shouldn't have used it, just a feeling she got. The next day, when some of the gel came out, she started to have traces of blood. She had not had any prior spotting or bleeding. She doesn't know how much rephresh played a role in what happened if at all. She has suffered recurring bacterial vaginosis for yrs.
Patient Sequence No: 1, Text Type: D, B5
[9937385]
The consumer did not report the event at the time of the occurrence. The consumer has used the product since the event without issue. The consumer was informed the mfr of the event because she is pregnant again and is interested in using the product during pregnancy. The consumer wondered in hindsight if rephresh might have been related to the miscarriage since the labeling advises to consult a doctor before use if pregnant.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003491851-2009-00001 |
| MDR Report Key | 2609673 |
| Report Source | 04 |
| Date Received | 2009-08-26 |
| Date of Report | 2009-08-26 |
| Date Mfgr Received | 2009-06-24 |
| Date Added to Maude | 2012-06-14 |
| 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 | TRICIA MILLER, DIR |
| Manufacturer Street | 1201 CONTINENTAL PL. N.E. |
| Manufacturer City | CEDAR RAPIDS IA 52402 |
| Manufacturer Country | US |
| Manufacturer Postal | 52402 |
| Manufacturer Phone | 3192943745 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | REPHRESH VAGINAL GEL |
| Generic Name | REPHRESH VAGINAL GEL |
| Product Code | MMS |
| Date Received | 2009-08-26 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LIL DRUG STORE PRODUCTS, INC. |
| Manufacturer Address | 1201 CONTINENTAL PL. N.E. CEDAR RAPIDS IA 52402 US 52402 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2009-08-26 |