MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-11-09 for SENSICARE 200 MDS2502 , MDS2503 , MDS2501 manufactured by .
[30708379]
Patient Sequence No: 1, Text Type: N, H10
[30708380]
Holes and tears in un-used gloves.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5210344 |
| MDR Report Key | 5210344 |
| Date Received | 2015-11-09 |
| Date of Report | 2015-10-15 |
| Date of Event | 2015-07-31 |
| Report Date | 2015-10-15 |
| Date Reported to FDA | 2015-10-15 |
| Date Reported to Mfgr | 2015-10-15 |
| Date Added to Maude | 2015-11-09 |
| 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 | 0 |
| 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 | 3 |
| Brand Name | SENSICARE 200 |
| Generic Name | POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE |
| Product Code | OPD |
| Date Received | 2015-11-09 |
| Returned To Mfg | 2015-08-03 |
| Model Number | MDS2502 , MDS2503 , MDS2501 |
| Lot Number | KOA507661944,TZH507691430, KOA507661949,KOA5077185 |
| Device Availability | R |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-11-09 |