MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2010-06-04 for NUTROPIN AQ PEN (SOMATROPIN) SOLUTION FOR INJECTION 10MG manufactured by Genentech, Inc..
[1408634]
Experienced injection site pain [injection site pain]. Case description: this spontaneous case was received from a pharmacist and concerned a male child of unreported age. The patient's medical history and concomitant medications were not reported. On an unknown date the patient started treatment with nutropin aq (somatropin), for an unknown indication. The dose, frequency and batch number were not reported. On an unknown date the patient experienced pain, bleeding and minor bruising, all occurring at the injection site. Action taken with nutropin aq was not reported. The outcome of the event was not reported. The reporter stated that the events were caused by the nutropin pen as it took 2-3 attempts to press the dose knob in order to administer the medication. Case correction performed on (b)(4)-2010: labelling for 'fault with nutropin pen' added as unlisted. No further information is expected.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2917293-2010-00007 |
| MDR Report Key | 1728638 |
| Report Source | 01,05 |
| Date Received | 2010-06-04 |
| Date of Report | 2010-05-10 |
| Date Mfgr Received | 2010-05-10 |
| Date Added to Maude | 2011-02-11 |
| 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 | 0 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | JAMES NICKAS, PHARM.D. |
| Manufacturer Street | 1 DNA WAY |
| Manufacturer City | SOUTH SAN FRANCISCO CA 94080 |
| Manufacturer Country | US |
| Manufacturer Postal | 94080 |
| Manufacturer Phone | 6502255591 |
| Manufacturer G1 | GENENTECH, INC. |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NUTROPIN AQ PEN (SOMATROPIN) SOLUTION FOR INJECTION 10MG |
| Generic Name | NONE |
| Product Code | KZE |
| Date Received | 2010-06-04 |
| Lot Number | NOT REPORTED |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GENENTECH, INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-06-04 |