MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2017-07-07 for CRITERION PURE NITRILE POWDER FREE EXAM GLOVES 9004485 manufactured by Cardinal Health Malaysia 211 Sdn.bhd.
[79252885]
Historical trending for the past 12 months was completed and this is the first complaint for this lot number. The device history record was reviewed and no abnormalities were noted. ? All manufacturing process controls 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. The need for corrective and/or preventive actions will be determined once the complaint sample 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 ans that 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
[79252886]
Based on the report received by our customer the doctor stated the gloves irritated his skin. He has never used this brand of gloves before. The doctor went to the dermatologist, however the treatment received is unknown. Once he stopped wearing the gloves the irritation went away. The doctor does not have any known allergies.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423537-2017-00115 |
| MDR Report Key | 6692517 |
| Report Source | DISTRIBUTOR |
| Date Received | 2017-07-07 |
| Date of Report | 2017-09-14 |
| Date of Event | 2017-06-14 |
| Date Facility Aware | 2017-06-15 |
| Report Date | 2017-07-07 |
| Date Reported to FDA | 2017-07-07 |
| Date Reported to Mfgr | 2017-06-15 |
| Date Mfgr Received | 2017-06-15 |
| Date Added to Maude | 2017-07-07 |
| 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 | PATRICIA TUCKER |
| 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 | CRITERION PURE NITRILE POWDER FREE EXAM GLOVES |
| Generic Name | PATIENT EXAMINATION GLOVE |
| Product Code | FMC |
| Date Received | 2017-07-07 |
| Returned To Mfg | 2017-06-28 |
| Model Number | 9004485 |
| Catalog Number | 9004485 |
| Lot Number | H1B165004 |
| Operator | PHYSICIAN |
| 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 | 2017-07-07 |