MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2015-07-16 for HENRY SCHEIN 102-5455 manufactured by A.r. Medicom Inc. (shanghai) Ltd..
[18269297]
Two female patients had experienced blistering and redness immediately after a routine procedure. As a result both female pts were prescribed kenalog cream to help treat the blistering and redness.
Patient Sequence No: 1, Text Type: D, B5
[18352811]
Two female patient had experienced blistering and redness immediately after a routine procedure. As a result both female pts were prescribed kenalog cream to help treat the blistering and redness.
Patient Sequence No: 2, Text Type: D, B5
| Report Number | 2411236-2015-00005 |
| MDR Report Key | 4924177 |
| Report Source | 99 |
| Date Received | 2015-07-16 |
| Date of Report | 2015-06-17 |
| Date of Event | 2015-06-17 |
| Date Facility Aware | 2015-06-17 |
| Report Date | 2015-07-16 |
| Date Reported to FDA | 2015-07-16 |
| Date Reported to Mfgr | 2015-07-14 |
| Date Added to Maude | 2015-07-21 |
| 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 | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HENRY SCHEIN |
| Generic Name | COTTON ROLLS #2 NON STERILE |
| Product Code | EFN |
| Date Received | 2015-07-16 |
| Catalog Number | 102-5455 |
| Lot Number | 18636 |
| Operator | OTHER |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | A.R. MEDICOM INC. (SHANGHAI) LTD. |
| Manufacturer Address | 938 XIANG JING ROAD SONJANG DISTRICT, SHANGHAI CH |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-07-16 |
| 2 | 0 | 1. Other | 2015-07-16 |