MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2010-04-09 for JP DRAIN manufactured by .
[14868881]
Event discovered during retrospective core measure review: physician/pa progress note of (b)(6) 2009 includes "jp: 10cc - removed - had to reopen le inc site to remove jp drain that broke. Remaining drain piece removed intact. Skin closed with staples. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1656763 |
| MDR Report Key | 1656763 |
| Report Source | 99 |
| Date Received | 2010-04-09 |
| Date of Report | 2010-04-06 |
| Date of Event | 2009-12-11 |
| Date Facility Aware | 2010-04-05 |
| Report Date | 2010-04-06 |
| Date Reported to FDA | 2010-04-07 |
| Date Added to Maude | 2010-04-16 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | JP DRAIN |
| Product Code | GBY |
| Date Received | 2010-04-09 |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2010-04-09 |