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.
[68210749]
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
[68210750]
Patient attempted to self remove device leading to edema was referred to surgical circumcision.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011215095-2017-00905 |
| MDR Report Key | 6355666 |
| Report Source | USER FACILITY |
| Date Received | 2017-02-24 |
| Date of Report | 2017-02-24 |
| Date of Event | 2016-12-10 |
| Date Mfgr Received | 2017-02-10 |
| 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 | 1. Required No Informationntervention | 2017-02-24 |