MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-10-14 for PURE GRIP POWDER FREE LATEX EXAM GLOVES 1032507 manufactured by Cardinal Health Malaysia 211 Sdn.bhd.
[57556207]
At the time of this investigation the glove manufacturer has reviewed the manufacturing process to ensure that it is running with the validated parameters and within normal process capability. All manufacturing process control and operating parameters during the production of this lot were within the validated specification and no abnormality was found. No change was made to the raw materials and suppliers, compounding formulation or manufacturing processes during the production of this lot. The pre-shipment quality inspection and testing of this lot passed all inspection and testing requirements prior to final shipment release. The need for corrective and/or preventive actions will be determined once the complaint samples are evaluated and/or tested. The 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 specifications prior to packing and release for shipment. It is to be noted that sensitivity of individuals to latex gloves may be a factor in developing skin irritations or allergic reactions from wearing such gloves.
Patient Sequence No: 1, Text Type: N, H10
[57556208]
Based on information received from the customer, the clinicians hands broke out from using the gloves. Per the customer, no serious injury. She did go to the dermatologist to get treated and was given medication that she could not remember the name. The clinician is doing well.
Patient Sequence No: 1, Text Type: D, B5
[61511500]
At the time of this investigation the glove manufacturer has reviewed the manufacturing process to ensure that it is running with the validated parameters and within normal process capability. All manufacturing process control and operating parameters during the production of this lot were within the validated specification and no abnormality was found. No change was made to the raw materials and suppliers, compounding formulation or manufacturing processes during the production of this lot. The pre-shipment quality inspection and testing of this lot passed all inspection and testing requirements prior to final shipment release. The glove manufacturer had submitted the returned glove samples to an accredited laboratory for chemical accelerators residual test. The test returned a result of nd (not detected) or the concentration was below the detectable limit for the identified chemicals, which appears to rule out the presence of residual chemical accelerators on the gloves that could potentially cause irritation or allergic reaction upon contact with skin.? Based on the above test results the root cause of the failure mode is unable to be determined.? The manufacturer will continue to ensure that the manufacturing process is stable as well as capable, process operating parameter? Are constantly monitored 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
| Report Number | 1423537-2016-00050 |
| MDR Report Key | 6031834 |
| Date Received | 2016-10-14 |
| Date of Report | 2016-12-05 |
| Date of Event | 2016-09-14 |
| Date Facility Aware | 2016-09-19 |
| Report Date | 2016-10-13 |
| Date Reported to FDA | 2016-10-13 |
| Date Reported to Mfgr | 2016-09-19 |
| Date Mfgr Received | 2016-09-19 |
| Date Added to Maude | 2016-10-14 |
| 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 | PURE GRIP POWDER FREE LATEX EXAM GLOVES |
| Generic Name | LATEX PATIENT EXAMINATION GLOVE |
| Product Code | LYY |
| Date Received | 2016-10-14 |
| Model Number | 1032507 |
| Catalog Number | 1032507 |
| Lot Number | H1G16A517 |
| Device Availability | N |
| 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 | 2016-10-14 |