MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,08 report with the FDA on 2014-05-15 for MICRO-TOUCH ELITE 3092 manufactured by Shijiazhuang Hongray Group Co., Ltd..
[4618148]
Our customer informed us that a clinician with known latex allergy developed severe allergic reaction after using our micro-touch elite powder free examination glove.
Patient Sequence No: 1, Text Type: D, B5
[11815372]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1019632-2014-00008 |
| MDR Report Key | 3839419 |
| Report Source | 05,08 |
| Date Received | 2014-05-15 |
| Date of Report | 2014-05-14 |
| Date Facility Aware | 2014-08-14 |
| Report Date | 2014-05-14 |
| Date Reported to FDA | 2014-05-14 |
| Date Reported to Mfgr | 2014-05-14 |
| Date Mfgr Received | 2014-05-14 |
| Device Manufacturer Date | 2011-11-01 |
| Date Added to Maude | 2014-05-30 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | TAMMY MCGRIFF |
| Manufacturer Street | 1635 INDUSTRIAL RD. |
| Manufacturer City | DOTHAN AL 36303 |
| Manufacturer Country | US |
| Manufacturer Postal | 36303 |
| Manufacturer Phone | 3346152566 |
| Manufacturer G1 | SHIJIAZHUANG HONGRAY GROUP CO., LTD |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MICRO-TOUCH ELITE |
| Generic Name | VINYL EXAMINATION GLOVES |
| Product Code | LYZ |
| Date Received | 2014-05-15 |
| Catalog Number | 3092 |
| Lot Number | 11117692DF |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SHIJIAZHUANG HONGRAY GROUP CO., LTD. |
| Manufacturer Address | SHIJIAZHUANG CITY, HEBEI PROVINCE CH |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-05-15 |