MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-07-10 for PEGINTRON REDIPEN 150 UG/0.5 ML manufactured by Schering-plough Labo Nv.
[4727061]
On (b)(6) 2014, merck was notified about a customer complaint concerning pegintron redipen. The complaint concerned a pharmacy tech who reported that "a pt's pegintron redipen" ejected all of the medication from the back of the pen onto the pt's hand and arm". This was when the pt had placed the needle into the insertion site and attempted to push down on the dosing button. The pt had heard a "crack" sound and that is when the medication ejected all of the medication. This medication did not go into the pt at all". No complaint sample was returned. The pen could therefore not be examined to verify whether a defect was present. The reported lot number of the complaint was (b)(4) and the expiry date was july 2015. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5037890 |
| MDR Report Key | 4037543 |
| Date Received | 2014-07-10 |
| Date of Report | 2014-07-10 |
| Date of Event | 2014-05-27 |
| Date Added to Maude | 2014-08-27 |
| 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 | PEGINTRON REDIPEN 150 UG/0.5 ML |
| Generic Name | NONE |
| Product Code | KZE |
| Date Received | 2014-07-10 |
| Lot Number | 2IRC60402 |
| Device Expiration Date | 2015-07-01 |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SCHERING-PLOUGH LABO NV |
| Manufacturer Address | INDUSTRIOPARK 30 - ZONE A HEIST-OP-DEN-BERG 2220 BE 2220 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-07-10 |