MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2017-04-07 for GLV EXAM PF SYN ESTEEM W/NEU-THERA SZ SM S88RX02 manufactured by Cardinal Health Malaysia 211 Sdn.bhd.
[72090788]
Historical trending for the past 12 months was completed: this is the 1st? Complaint for this glove type and failure mode. The device history record was reviewed and no abnormality noted. ? All manufacturing process control and operating parameters were within the validated specification and no abnormality was found. No change was made to the raw materials and suppliers, compounding formulation, or manufacturing process during the production of this lot. Pre-shipment quality inspection of this lot passed all inspection requirements prior to final shipment release. Returned complaint gloves did not exhibit any visible abnormality. The need for corrective and/or preventive actions will be determined once the complaint samples testing is completed. It is to be noted that sensitivity of individuals to synthetic/vinyl gloves may be a factor in developing or allergic reaction or skin irritation from wearing such gloves. The glove manufacturer will continue to ensure that the manufacturing process is stable as well as capable, good manufacturing practices are adhered to and continuous improvement strategies are implemented in order to ensure gloves are consistently produced according to the required specification prior to packing and release for shipment.
Patient Sequence No: 1, Text Type: N, H10
[72090789]
Based on information received from the customer an employee was wearing gloves s88rx02. The employee then broke out in hives. The employee went to employee health and was provided benadryl. This was the first time the employee wore these gloves.? She is doing fine now.
Patient Sequence No: 1, Text Type: D, B5
[78167631]
Returned complaint glove samples did not exhibit any visible abnormality and no allergic reaction or skin irritation was reported by the glove manufacturing plant personnel from donning the gloves at an-hour's stretch. Dermal irritation test returned a conclusion that the irritation of test substance is negligible on test sample skins and that the primary irritation index (pii) of test material was? 0? , which appears to rule out the possibility that the gloves could potentially cause allergic reaction or irritation upon contact with skin. It is to be noted that sensitivity of certain individuals to nitrile gloves may be a factor in developing allergic reaction or skin irritation from wearing such gloves. Manufacturing process was reviewed by the glove manufacturer to ensure it is running with the validated parameters and within normal process capability. ? The glove manufacturer will continue to ensure that the manufacturing process is stable as well as capable, good manufacturing practices are adhered to and continuous improvement strategies are implemented to ensure gloves are consistently produced according to the required specification prior to packing and release for shipment.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1423537-2017-00080 |
| MDR Report Key | 6471591 |
| Report Source | OTHER |
| Date Received | 2017-04-07 |
| Date of Report | 2017-06-05 |
| Date of Event | 2017-03-14 |
| Date Facility Aware | 2017-03-14 |
| Date Mfgr Received | 2017-03-14 |
| Date Added to Maude | 2017-04-07 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MICHELE DONATICH |
| Manufacturer Street | 1500 WAUKEGAN RD |
| Manufacturer City | WAUKEGAN IL 60085 |
| Manufacturer Country | US |
| Manufacturer Postal | 60085 |
| 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 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GLV EXAM PF SYN ESTEEM W/NEU-THERA SZ SM |
| Generic Name | VINYL PATIENT EXAMINATION GLOVE |
| Product Code | LYZ |
| Date Received | 2017-04-07 |
| Returned To Mfg | 2017-04-03 |
| Model Number | S88RX02 |
| Catalog Number | S88RX02 |
| Lot Number | 4Y14J007 |
| Operator | SPEECH THERAPIST |
| Device Availability | R |
| 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 | 2017-04-07 |