MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-02 for RAYTEC - DENTAL PACK 3620936 SEN21DEDCA manufactured by Cardinal Health 200, Llc.
[141014678]
Sds opened another dental pack today what had only 9 of the 2x2 sponges and should have had 10. They removed them from the field and used the rest of the pack. They added a separate pack of 3x3 sponges in place of the 2x2 sponges. Pack info is as follows: cat# sen21dedca. Exp date: 09/01/2023, mfg date: 02/11/2019. Lot 184967, model# 3620936.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5085550 |
| MDR Report Key | 8479654 |
| Date Received | 2019-04-02 |
| Date of Report | 2019-03-19 |
| Date of Event | 2019-03-19 |
| Date Added to Maude | 2019-04-03 |
| 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 | RISK MANAGER |
| 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 | RAYTEC - DENTAL PACK |
| Generic Name | GENERAL PURPOSE DENTAL TRAY |
| Product Code | OFX |
| Date Received | 2019-04-02 |
| Model Number | 3620936 |
| Catalog Number | SEN21DEDCA |
| Lot Number | 184967 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARDINAL HEALTH 200, LLC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-04-02 |