MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-06-13 for SUPPRELIN 50MG KIT manufactured by Endo Pharmaceuticals.
[2057882]
The supprelin implant was placed in the delivery device and tested prior to use. The physician tunnelled the device in the subcutaneous tissue. The physician was unable to withdraw the plunger, a step that is necessary to leave the implant in the tissue. The physician withdrew the delivery device from the pt's arm. The physician still could not withdraw the plunger. The physician grasped the implant and removed it from the delivery device. The end of the implant had been sheared off by the delivery device. The implant was not useable. The implant was leaking fluid through the end that had been trapped in the delivery device. The physician contacted the drug representative regarding this event. The physician had previously complained to the drug representative regarding the poor manufacturing quality of the delivery device. Diagnosis or reason for use: precocious puberty.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5020974 |
| MDR Report Key | 2132621 |
| Date Received | 2011-06-13 |
| Date of Report | 2011-06-13 |
| Date of Event | 2011-06-02 |
| Date Added to Maude | 2011-06-21 |
| 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 | 3 |
| Reporter Occupation | PHARMACIST |
| Health Professional | 3 |
| 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 | SUPPRELIN 50MG KIT |
| Generic Name | IMPLANT DELIVERY DEVICE |
| Product Code | FGY |
| Date Received | 2011-06-13 |
| Lot Number | 6076914 |
| ID Number | 67979-0002-01 |
| Device Expiration Date | 2012-09-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ENDO PHARMACEUTICALS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2011-06-13 |