MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-10-13 for PECO TOUCH-FREE CATHETERIZATION SYSTEM PK5214 manufactured by Peco Medical, Inc..
[5102373]
Received peco touch-free catheterization system, ref pk5214, lot 1112121e, expiry date 12//11/2014 (which i understand is december 2014) burt the povidone-iodine swabs are already expired. The aplicare pvp inside the urinary catheter kits are expired. Withpvp-iodine swab (b)(4) from aplicare with expiry date 11/2013.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5038594 |
| MDR Report Key | 4181750 |
| Date Received | 2014-10-13 |
| Date of Report | 2014-10-13 |
| Date Added to Maude | 2014-10-21 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PECO TOUCH-FREE CATHETERIZATION SYSTEM |
| Generic Name | PECO TOUCH-FREE CATHETERIZATION SYSTEM |
| Product Code | EYZ |
| Date Received | 2014-10-13 |
| Model Number | PK5214 |
| Lot Number | 1112121E |
| Device Expiration Date | 2014-12-11 |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PECO MEDICAL, INC. |
| Manufacturer Address | 7640 FULLERTON RD. STE 200 SPRINGFIELD VA 22153 US 22153 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-10-13 |