MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-23 for ADAPTOR, HOLDER, SYRINGE manufactured by Abbvie Medical Device Center.
[125105757]
Pt says that gray needle cover does not look right on his current pen. "event resolved, provided mfr's phone. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5080791 |
| MDR Report Key | 7999925 |
| Date Received | 2018-10-23 |
| Date of Report | 2018-10-18 |
| Date of Event | 2018-10-17 |
| Date Added to Maude | 2018-10-24 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 | ADAPTOR, HOLDER, SYRINGE |
| Generic Name | ADAPTOR, HOLDER, SYRINGE |
| Product Code | IQG |
| Date Received | 2018-10-23 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABBVIE MEDICAL DEVICE CENTER |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-10-23 |