MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2011-05-19 for MEDICHOICE ETS NITRILE PATIENT EXAM GLOVES 1773GLV2001 manufactured by Kossan Latex Industries Sdn. Bhd..
[2148271]
Cypress initially received a user's facility report # (b)(4) through the distributor, (b)(4). This report was regarding three nurses in the facility's sicu developing a rash after introduction of the medichoice ets nitrile gloves. Then, cypress learned of three more nurses reportedly from a different unit experiencing the same issue. Recently, the facility reported to the distributor, owens & minor, that they are amending their initial medwatch report because they had determined that all six nurses are from the same unit. Cypress does not have a copy of the amendment.
Patient Sequence No: 1, Text Type: D, B5
[9019728]
Add'l catalog numbers: 1773glv2002, 1773glv2003 and 1773glv2004. Add'l lot numbers: mok01-04, moj11-05.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005632797-2011-00001 |
| MDR Report Key | 2110901 |
| Report Source | 06 |
| Date Received | 2011-05-19 |
| Date of Report | 2011-04-21 |
| Date of Event | 2011-03-14 |
| Date Facility Aware | 2011-04-15 |
| Report Date | 2011-04-25 |
| Date Reported to FDA | 2011-04-21 |
| Date Reported to Mfgr | 2011-04-21 |
| Date Mfgr Received | 2011-04-21 |
| Date Added to Maude | 2012-06-12 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Street | LOT 6129 5 1/4 MILES JALAN HAJ ABDUL MANAN, JALAN MERU |
| Manufacturer City | KLANG, SELANGOR DARUL EHSAN 41050 |
| Manufacturer Country | MY |
| Manufacturer Postal | 41050 |
| Manufacturer Phone | 33927616 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MEDICHOICE ETS NITRILE PATIENT EXAM GLOVES |
| Generic Name | NITRILE EXAM GLOVES |
| Product Code | LZC |
| Date Received | 2011-05-19 |
| Returned To Mfg | 2011-04-13 |
| Catalog Number | 1773GLV2001 |
| Lot Number | MOJ07-07 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 10 MO |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KOSSAN LATEX INDUSTRIES SDN. BHD. |
| Manufacturer Address | LOT 6129 5 1/4 MILES JALAN HAJ ABDUL MANAN, JALAN MERU KLANG, SELANGOR DARUL EHSAN 41050 MY 41050 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2011-05-19 |