MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2017-10-20 for ALCAVIS 50 15501 manufactured by Angelini Pharma Inc..
[89920046]
Device not returned.
Patient Sequence No: 1, Text Type: N, H10
[89920047]
Angelini pharma inc. Was received a complaint filled with (b)(4) about an adverse event involving alcavis 50. On march 1st, (b)(4) was contacted by the patient about an incident that happened on (b)(6) 2017. The patient stated that while using alcavis 50 to clean the catheter while preparing for his peritoneal dialysis, he spilled alcavis 50 on his underpants. He did not notice that his underwear was wet and went to bed with the wet garments. In the next morning, he felt that the genital area was uncomfortable and noticed his underpants was discolored. He then realized that he had spilled alcavis 50 on himself and went to bed without exchange it. He noticed that the genitals were reddish and sensitive; he then showered and washed the affected area with antimicrobial soap, treated with hydrogen peroxide, and with triple antibiotic ointment. Two/three days later, he had a visit with his nephrologist who referred him to the primary doctor, and this to his urologist. With the urologist, he began treatment with lidocaine gel (4%) and clotrimazole and betamethasone dipropionate cream. Region is still having an open would and is still painful. Patient is diabetic and undergoes hyperbaric treatment. Patient continues using alcavis 50.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3001239013-2017-00001 |
| MDR Report Key | 6966376 |
| Report Source | CONSUMER |
| Date Received | 2017-10-20 |
| Date of Report | 2017-03-31 |
| Date of Event | 2017-01-23 |
| Date Mfgr Received | 2017-03-01 |
| Date Added to Maude | 2017-10-20 |
| 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 Contact | MRS. VALERIA SENA-WELTIN |
| Manufacturer Street | 8322 HELGERMAN CT |
| Manufacturer City | GAITHERSBURG MD 208774103 |
| Manufacturer Country | US |
| Manufacturer Postal | 208774103 |
| Manufacturer Phone | 3013307597 |
| Single Use | 3 |
| Remedial Action | PM |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ALCAVIS 50 |
| Generic Name | HIGH LEVEL DISINFECTANT FOR CONNECTIONS |
| Product Code | FKO |
| Date Received | 2017-10-20 |
| Catalog Number | 15501 |
| Operator | PATIENT FAMILY MEMBER OR FRIEND |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ANGELINI PHARMA INC. |
| Manufacturer Address | 8322 HELGEMAN CR GAITHERSBURG MD 208774103 US 208774103 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-10-20 |