MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2019-04-12 for GLV EXAM NITRILE ESTEEM MOIST PF SM N88RX02T manufactured by Cardinal Health Malaysia 211 Sdn.bhd.
[141750648]
Two lot numbers were provided by the customer. A device history record review was conducted on lot numbers 5w18l012 and 5w18s001. No exception was recorded in the device history records that could lead to the reported incident. Based on supplier investigation, the device history record review did not indicate any exception that could lead to the reported incident. Manufacturing checked the raw material supply, the formulation, the production process and the retained samples, no abnormality was found. The raw materials are coming from the qualified suppliers and it is tested by the lab before use. In the compounding process, the raw materials are mixed by formulation and the parameters are controlled within level and no abnormal situation occurred. One box of samples were returned for lot number 5w18s001. Samples have been forwarded on for skin irritation testing. Manufacturing reviewed irritation test reports conducted in 2010, the test results show that there is not a primary dermal irritant. At this time the root cause could not be determined. Manufacturing will intensify the inspection of the parameters during production, to ensure they are within the standard, and increase the donning test.
Patient Sequence No: 1, Text Type: N, H10
[141750649]
Based on information received from the customer, the lab tech reportedly had a skin reaction to the glove. They sought medical treatment, however the treatment they received is unknown. Two lot numbers were provided by the customer; however, they are unsure as to the lot number that may have caused the skin irritation. The lab tech is now using a cloth liner under the glove.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423537-2019-00306 |
| MDR Report Key | 8508720 |
| Report Source | USER FACILITY |
| Date Received | 2019-04-12 |
| Date of Report | 2019-05-28 |
| Date of Event | 2019-03-20 |
| Date Mfgr Received | 2019-03-20 |
| Date Added to Maude | 2019-04-12 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 | PATRICIA TUCKER |
| Manufacturer Street | 3651 BIRCHWOOD DRIVE |
| Manufacturer City | WAUKEGAN IL 60085 |
| Manufacturer Country | US |
| Manufacturer Postal | 60085 |
| Manufacturer Phone | 8478874151 |
| Manufacturer G1 | CARDINAL HEALTH MALAYSIA 211 SDN.BHD |
| Manufacturer Street | ZONE PHASE IV, MK 12 LINTANG , |
| Manufacturer City | BAYAN LEPAS 11900 |
| Manufacturer Country | MY |
| Manufacturer Postal Code | 11900 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GLV EXAM NITRILE ESTEEM MOIST PF SM |
| Generic Name | PATIENT EXAMINATION GLOVE, SPECIALTY |
| Product Code | LZC |
| Date Received | 2019-04-12 |
| Model Number | N88RX02T |
| Catalog Number | N88RX02T |
| Lot Number | 5W18S001 |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARDINAL HEALTH MALAYSIA 211 SDN.BHD |
| Manufacturer Address | ZONE PHASE IV, MK 12 LINTANG , BAYAN LEPAS 11900 MY 11900 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-04-12 |