MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2019-04-17 for HYALOGYN 179604 manufactured by Fidia Farmaceutici S.p.a..
[142260260]
(b)(4). This is a spontaneous report from a consumer, received through (b)(4). A patient, after the use of the product hyalogyn, experienced allergic reaction to excipient, vaginal bleeding and urinary tract infection in a context of medication error. In fact, the patient was prescribed hyalogyn, but she had a known allergy to propylene glycol that is an ingredient of the product. The case has been deemed as serious by the company due to medically important condition. The case has been deemed as serious/expected for allergic reaction to excipient (propylene glycol) as a proven hypersensitivity to a component of the product and serious/unexpected for vaginal bleeding and urinary tract infection since they are not listed in the label of the product. The causality relationship has been evaluated as definite for allergic reaction to excipient, as possible for vaginal bleeding, since the event could be likely related to the extreme vaginal dryness of the patient, and as possible for urinary tract infection. In fact, there is a temporal relationship between the use of hyalogyn and the onset of the urinary tract infection but there is no scientific grounds to relate the infection to the product. The batch number is not currently available for an investigation. If new information come to light, the case will be re-evaluated. The condition of medication error is not assessable.
Patient Sequence No: 1, Text Type: N, H10
[142260261]
This is a serious, spontaneous adverse event reported by a (b)(6) female consumer involving hyalogyn. It is not a medical confirmed case. The patient is on no medications except the antibiotic macrabid which was prescribed as a result of this adverse event. The consumers gynecologist recommended she try hyalogyn for extremely dry vagina. The consumer prefers to use only all natural products due to allergies, which is why her physician recommended hyalogyn. She purchased the product and applied it intravaginally as indicated in the labeling on (b)(6) 2019. The consumer reported that she initially experienced some initial burning, discomfort and irritation but initially dismissed it due to the extreme dryness of the vaginal tissue. The pain, burning and irritation increased over the next two days. She also began to experience some mild bleeding. She contacted her gynecologist on (b)(6) 2019 and was immediately seen in the clinic. The physician performed a physical exam, noted that the vagina was irritated and red. A urine specimen was tested and was positive for a urinary tract infection. The patient did not use the product again and the physician prescribed the antibiotic macrobid for a seven day regimen. The patient finished the antibiotic, taking her last dose on (b)(6) 2019. She will return to the physician's office on (b)(6) 2019 for a follow-up exam. At the time of this report the consumer's symptoms had improved. She no longer feels any pain, bleeding, burning or irritation of the vagina.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610200-2019-00004 |
| MDR Report Key | 8523258 |
| Report Source | CONSUMER |
| Date Received | 2019-04-17 |
| Date of Report | 2019-04-17 |
| Date of Event | 2019-03-24 |
| Date Facility Aware | 2018-04-03 |
| Report Date | 2019-04-03 |
| Date Reported to Mfgr | 2019-04-03 |
| Date Mfgr Received | 2019-04-03 |
| Date Added to Maude | 2019-04-17 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR GIUSEPPE DI SANTE |
| Manufacturer Street | VIA PONTE DELLA FABBRICA, 3/A |
| Manufacturer City | ABANO TERME, PADUA 35031 |
| Manufacturer Country | IT |
| Manufacturer Postal | 35031 |
| Manufacturer G1 | FIDIA FARMACEUTICI S.P.A. |
| Manufacturer Street | VIA PONTE DELLA FABBRICA, 3/A |
| Manufacturer City | ABANO TERME, PADUA 35031 |
| Manufacturer Country | IT |
| Manufacturer Postal Code | 35031 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HYALOGYN |
| Generic Name | HYALOGYN VAGINAL HYDRATING GEL |
| Product Code | NUC |
| Date Received | 2019-04-17 |
| Catalog Number | 179604 |
| Lot Number | UNK |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | FIDIA FARMACEUTICI S.P.A. |
| Manufacturer Address | VIA PONTE DELLA FABBRICA 3/A ABANO TERME, PADUA 35031 IT 35031 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-04-17 |