MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2017-04-27 for GLV EXAM PF THIN NITRILE FINGER TEX SM 88TN02S manufactured by Cardinal Health Malaysia 211 Sdn.bhd.
[73812422]
Historical trending for the past 12 months was completed: this is the 1st? Complaint for this lot number for this type of report. 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 arrived on 4/25/2017. 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 nitrile gloves may be a factor in developing skin irritation or allergic reaction 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. A follow-up report will be filed once the sample evaluation has been completed.
Patient Sequence No: 1, Text Type: N, H10
[73812423]
Based on the report received by the customer an employee went to employee health on (b)(6) 2017 and then to the emergency room on (b)(6) 2017 due to contact dermatitis. She was given? Hydrocortisone and benadryl by er.
Patient Sequence No: 1, Text Type: D, B5
[77965583]
The returned glove samples were tested and did not exhibit any visible abnormality, ph reading is close to the neutral value, no skin irritation was reported by the glove manufacturing plant personnel from donning the glove at a 2-hour stretch. Residual chemical accelerator test returned a result of? Not detected? Or the concentration was below the detectable limit, which appears to rule out the presence of residual chemical accelerators on the gloves that could potentially cause irritation upon contact with skin. It is to be noted that sensitivity of certain individuals to nitrile gloves may be a factor in developing skin irritation or allergic reaction 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. ? Manufacturing will continue to ensure leaching process is carried out according to the validated process parameter. 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. Based on the testing performed we are unable to determine a root cause for the issue reported for this incident.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1423537-2017-00086 |
| MDR Report Key | 6525560 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2017-04-27 |
| Date of Report | 2017-06-07 |
| Date of Event | 2017-03-27 |
| Date Facility Aware | 2017-04-03 |
| Date Mfgr Received | 2017-04-03 |
| Date Added to Maude | 2017-04-27 |
| 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 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GLV EXAM PF THIN NITRILE FINGER TEX SM |
| Generic Name | PATIENT EXAMINATION GLOVE |
| Product Code | FMC |
| Date Received | 2017-04-27 |
| Returned To Mfg | 2017-04-25 |
| Model Number | 88TN02S |
| Catalog Number | 88TN02S |
| Lot Number | 6B16P544 |
| 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 | 2017-04-27 |