MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-11-15 for PURE GRIP POWDER FREE LATEX EXAM GLOVES 1032507 manufactured by Cardinal Health Malaysia 211 Sdn.bhd.
[59974467]
As lot number and complaint sample were not available to review device history records, analyze the defect and determine root-cause, corrective or preventive action for this reported failure mode is unable to be defined. ? The glove manufacturer of this product will continue to ensure that the manufacturing process is stable as well as capable 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.
Patient Sequence No: 1, Text Type: N, H10
[59974468]
Based on the report received on 10/24/16 approximately two months ago a staff member was wearing these gloves when they had difficulty breathing. They went to the emergency room and was seen by an allergist. Blood tests were done on the staff member, however they did not know the names of the tests. At the time of this report the customer was unable to provide the lot number or a sample. The staff member is doing well.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423537-2016-00058 |
| MDR Report Key | 6104078 |
| Date Received | 2016-11-15 |
| Date of Report | 2016-11-15 |
| Date of Event | 2016-10-24 |
| Date Facility Aware | 2016-10-24 |
| Report Date | 2016-11-15 |
| Date Reported to FDA | 2016-11-15 |
| Date Reported to Mfgr | 2016-10-28 |
| Date Mfgr Received | 2016-10-24 |
| Date Added to Maude | 2016-11-15 |
| 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 | 0 |
| Brand Name | PURE GRIP POWDER FREE LATEX EXAM GLOVES |
| Generic Name | LATEX PATIENT EXAM GLOVES |
| Product Code | LYY |
| Date Received | 2016-11-15 |
| Model Number | 1032507 |
| Catalog Number | 1032507 |
| Lot Number | UNKNOWN |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| 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 | 2016-11-15 |