MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2017-02-24 for PREPEX manufactured by Circ Medtech.
[68210741]
Device displacement or dislodgement will occur when patient moves the device in some manner contrary to instructions and counseling given on the day of placement. The information as to how the event occurred is often unavailable. No manufacturer investigation was undertaken since this was a foreseen risk in device usage and is clearly noted both in the ifu and the training program. We have attached a copy of the ifu with the relevant text highlighted.
Patient Sequence No: 1, Text Type: N, H10
[68210742]
Device dislodgement, reason unknown, leading to edema, patient was referred to surgical circumcision.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011215095-2017-00925 |
| MDR Report Key | 6355957 |
| Report Source | USER FACILITY |
| Date Received | 2017-02-24 |
| Date of Report | 2017-02-24 |
| Date of Event | 2017-01-01 |
| Date Mfgr Received | 2017-02-02 |
| Date Added to Maude | 2017-02-24 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS OSSIE MILANOV |
| Manufacturer Street | 1 HANAGAR ST. |
| Manufacturer City | HOD HASHARON, 4501305 |
| Manufacturer Country | IS |
| Manufacturer Postal | 4501305 |
| Manufacturer Phone | 97994949 |
| Manufacturer G1 | 3BY |
| Manufacturer Street | TEFEN INDUSTRIAL ZONE |
| Manufacturer City | TEFEN, 24959 |
| Manufacturer Country | IS |
| Manufacturer Postal Code | 24959 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PREPEX |
| Generic Name | PREPEX |
| Product Code | HFX |
| Date Received | 2017-02-24 |
| Operator | NURSE |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CIRC MEDTECH |
| Manufacturer Address | 1 HANAGAR ST. HOD HASHARON, 4501305 IS 4501305 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-02-24 |