MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-04-11 for MONOJECT SYRINGE 1186000777T manufactured by Covidien/medtronic.
[72840448]
There was a hair found in a sterile packaged monoject 60ml syringe.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5069052 |
| MDR Report Key | 6489353 |
| Date Received | 2017-04-11 |
| Date of Report | 2017-04-11 |
| Date of Event | 2017-04-07 |
| Date Added to Maude | 2017-04-13 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | MONOJECT SYRINGE |
| Generic Name | MONOJECT SYRINGE |
| Product Code | PNR |
| Date Received | 2017-04-11 |
| Model Number | 1186000777T |
| Lot Number | 14F16 |
| Device Expiration Date | 2019-05-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN/MEDTRONIC |
| Manufacturer Address | MANSFIELD MA 02048 US 02048 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-04-11 |