MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-25 for HENRY SCHEIN INC. 112-5532 manufactured by Kossan Latex Industries (m) Sdn Bhd.
[143231787]
A female dental assistant was wearing latex gloves when she started having difficulty breathing and her throat started to feel as if it was swelling. The assistant stated she believes she has an allergy to rubber, elastic and latex from years of wearing these materials. The assistant did not seek any medical attention and was not prescribed any medication, nor did she take any otc medications to treat the reaction. The swelling was reported to subside on its own.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2411236-2019-00003 |
| MDR Report Key | 8552255 |
| Date Received | 2019-04-25 |
| Date of Report | 2019-04-03 |
| Date of Event | 2019-04-03 |
| Date Facility Aware | 2019-04-03 |
| Report Date | 2019-04-25 |
| Date Reported to FDA | 2019-04-25 |
| Date Reported to Mfgr | 2019-04-25 |
| Date Added to Maude | 2019-04-25 |
| 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 INC. |
| Generic Name | LATEX PATIENT EXAMINATION GLOVE |
| Product Code | LYY |
| Date Received | 2019-04-25 |
| Catalog Number | 112-5532 |
| Lot Number | K10048407 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KOSSAN LATEX INDUSTRIES (M) SDN BHD |
| Manufacturer Address | LOT6129 JALAN HAJI ABDUL MANAN BATU 5 1/4 JALAN MERU, KLANG 41050 MY 41050 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-04-25 |