MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-01-06 for HENRY SCHEIN manufactured by .
[64134888]
Patient Sequence No: 1, Text Type: N, H10
[64134889]
The customer reports 30-45 minutes after a root canal procedure a patient experienced swelling that developed on their left cheek and neck. The patient was taken to the hospital by ambulance. While in the ambulance the patient was administrated (b)(6) and when at the hospital the patient was given a cortisone shot. The patient stayed the night in the hospital and has made a full recovery.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005497907-2016-00001 |
| MDR Report Key | 6231231 |
| Date Received | 2017-01-06 |
| Date Mfgr Received | 2016-12-13 |
| Device Manufacturer Date | 2015-08-06 |
| Date Added to Maude | 2017-01-06 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS CHRISTINE CHOO |
| Manufacturer Street | 6B 2ND FLOOR, PRSN GREENTOWN 4 GREENTOWN AVENUE |
| Manufacturer City | IPOH, PERAK 30250 |
| Manufacturer Country | MY |
| Manufacturer Postal | 30250 |
| Manufacturer Phone | 052553939 |
| Manufacturer G1 | SANCTUARY HEALTH SDN BHD |
| Manufacturer Street | NO 16 PRSN PERIND KANTHAN 1 KWS PERIND KANTHAN |
| Manufacturer City | CHEMOR, PERAK 31200 |
| Manufacturer Country | MY |
| Manufacturer Postal Code | 31200 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | HENRY SCHEIN |
| Generic Name | DENTAL DAM 6X6 GREEN |
| Product Code | EIE |
| Date Received | 2017-01-06 |
| Device Availability | * |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-01-06 |