MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-09-30 for JARIT 350-370 100088-1401 manufactured by Jarit.
[56448857]
When using a 2 prong skin hook a piece came off the metal skin hook which was then secured and not left in the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5065158 |
| MDR Report Key | 5996424 |
| Date Received | 2016-09-30 |
| Date of Report | 2016-09-30 |
| Date of Event | 2016-09-29 |
| Date Added to Maude | 2016-10-04 |
| 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 | JARIT 350-370 |
| Generic Name | SKIN HOOK |
| Product Code | KCH |
| Date Received | 2016-09-30 |
| Model Number | 100088-1401 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | JARIT |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-09-30 |