MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-20 for ANSELL GAMMEX NON LATEX PI 816734 20685765 manufactured by Ansell N.p. Sdn. Bhd..
[139416692]
Review of the device history records indicated no abnormalities were found. Production records show that lot met the standard requirement prior to shipment release. The lot passed all the required inspections and criteria were performed according to the established procedures. No significant changes were made to the manufacturing process. Glove formulation was modified to reduce the risk of type iv allergy by eliminating certain higher risk chemicals (mainly accelerators) from the formulation and to ensure compliance with an ever more stringent regulatory environment. Returned and retained sample analysis show no abnormalities. Fit kit test that measures major allergens was performed with no detection determined. This indicates a very low probability that the gloves could have cause an allergic reaction. Chemical residue test measuring presence of accelerators and antioxidants residue show no abnormalities were found. Based on the investigation, there were no deviations nor evidence of special causes that would have led to an allergic reaction. As a result, no corrective action was rendered at this time.
Patient Sequence No: 1, Text Type: N, H10
[139416693]
Incident occurred on (b)(6) 2018 in (b)(6). The customer states an employee experienced an allergic reaction while wearing ansell gammex non-latex pi surgical gloves and developed a burning/itching sensation and pink rash on her hands. The rash spread to her upper arms and then to her chest with welts. The employee was treated in the emergency room for an allergic reaction. She had elevated heart rate despite treatment and was admitted to icu due to tachycardia. She was discharged from icu after 2-3 nights.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011209798-2019-00001 |
| MDR Report Key | 8438033 |
| Date Received | 2019-03-20 |
| Date of Report | 2019-03-20 |
| Date of Event | 2018-12-26 |
| Date Facility Aware | 2018-11-27 |
| Report Date | 2019-03-20 |
| Date Reported to FDA | 2019-03-20 |
| Date Reported to Mfgr | 2018-11-28 |
| Date Added to Maude | 2019-03-20 |
| 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 |
| 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 | 0 |
| Brand Name | ANSELL GAMMEX NON LATEX PI |
| Generic Name | SURGICAL GLOVES |
| Product Code | KGO |
| Date Received | 2019-03-20 |
| Model Number | 816734 |
| Catalog Number | 20685765 |
| Lot Number | 1804450404 |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ANSELL N.P. SDN. BHD. |
| Manufacturer Address | LOT 80 KAWASAN MELAKA, 75450 MY 75450 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2019-03-20 |