MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-12-12 for HENRY SCHEIN 101-1505 manufactured by Sanctuary Health Sdn Bhd.
[62122476]
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 administered benadryl 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 | 2411236-2016-00007 |
| MDR Report Key | 6166243 |
| Date Received | 2016-12-12 |
| Date of Report | 2016-11-16 |
| Date of Event | 2016-11-15 |
| Report Date | 2016-12-12 |
| Date Reported to FDA | 2016-12-12 |
| Date Reported to Mfgr | 2016-12-12 |
| Date Added to Maude | 2016-12-12 |
| Event Key | 0 |
| Report Source Code | Distributor 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 | DENTIST |
| 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 | HENRY SCHEIN |
| Generic Name | DENTAL DAM 6X6 GREEN |
| Product Code | EIE |
| Date Received | 2016-12-12 |
| Catalog Number | 101-1505 |
| Lot Number | 060815 |
| Operator | DENTIST |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SANCTUARY HEALTH SDN BHD |
| Manufacturer Address | NO.16 PERSIARAN PERINDUSTRIAN1 KAWASAN PERINDUSTRIAN KANTHAN CHEMOR PERAK, 31200 MY 31200 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-12-12 |