MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,07 report with the FDA on 2014-03-20 for NONE manufactured by .
[4331219]
End-user reports that he accidently used product while masturbating and immediately felt tingling which progressed to burning. States he is embarrassed and did not wish to give last name or address. After masturbating; washed but continues to feel some tingling and minor burning and now has a priapism.
Patient Sequence No: 1, Text Type: D, B5
[11760112]
Based on the available info, this event is deemed a serious injury. It is reported that end-user has not seen a physician. Covatec's customer service nurse are commended washing effected site again to remove any residual ointment, and if end-user continues to experience symptoms, especially priapism, end-user should contact his health care provider. No additional pt/event details have been provided to date. A return sample for evaluation is not expected. Should additional info becomes available, a follow-up report will be submitted reported to the fda. Third party manufacturer: (b)(4). Convatec will continue to track and monitor such complaints according to it's complaint handling and capa procedures.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2243969-2014-00096 |
| MDR Report Key | 3717112 |
| Report Source | 04,07 |
| Date Received | 2014-03-20 |
| Date of Report | 2014-02-25 |
| Date of Event | 2014-02-25 |
| Date Mfgr Received | 2014-02-25 |
| Date Added to Maude | 2014-04-02 |
| 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 | MATTHEW WALENCIAK, ASSOC DIRECTOR |
| Manufacturer Street | 200 HEADQUARTERS PARK DRIVE |
| Manufacturer City | SKILLMAN NJ 08558 |
| Manufacturer Country | US |
| Manufacturer Postal | 08558 |
| Manufacturer Phone | 9089042287 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | NONE |
| Product Code | KOY |
| Date Received | 2014-03-20 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-03-20 |