MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2014-03-10 for COVER GOWN, YELLOW 2100PG manufactured by Cardinal Health.
[21049474]
Nurse had a reaction of facial itching and hives. She was treated in the e. R. On (b)(6) 2014 and started on prednisone and benadryl. On (b)(6) 2014, cardinal health learned that this nurse also apparently had a reaction to the gown back in 2013 ((b)(6) 2013) and sought medical care at that time. She switched to a different gown and was doing fine until (b)(6) 2014 when during a patient emergency she used this gown again. Per the customer, it is unclear if this recent reaction was due to the gown or due to the mask that was used by the nurse. Cardinal health is proactively filing this report.
Patient Sequence No: 1, Text Type: D, B5
[21164706]
Since there was no lot number or sample available, we are unable to review the device history record or conduct an investigation to determine if there was any deviation that could have led to this complaint. Therefore the root cause could not be determined. Historical trending was done. This product is made of polypropylene with calcium carbonate fillers. The material has passed a series of tests prescribed by regulatory agencies for the intended use. The complaint was feedback to the relevant production personnel. At this time there will be no corrective action, but we will continue to monitor complaints for any trends of this nature.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1423537-2014-00011 |
| MDR Report Key | 3671056 |
| Report Source | 05,07 |
| Date Received | 2014-03-10 |
| Date of Report | 2014-03-10 |
| Date of Event | 2014-01-18 |
| Date Mfgr Received | 2014-02-10 |
| Date Added to Maude | 2014-03-11 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MICHELE DONATICH |
| Manufacturer Street | 1430 WAUKEGAN ROAD |
| Manufacturer City | MCGAW PARK IL 60085 |
| Manufacturer Country | US |
| Manufacturer Postal | 60085 |
| Manufacturer Phone | 8478876412 |
| Manufacturer G1 | CARDINAL HEALTH 200, LLC |
| Manufacturer Street | 1430 WAUKEGAN RD |
| Manufacturer City | WAUKEGAN 60085 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 60085 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COVER GOWN, YELLOW |
| Generic Name | ISOLATION GOWN |
| Product Code | FYC |
| Date Received | 2014-03-10 |
| Catalog Number | 2100PG |
| Lot Number | NO LOT GIVEN |
| Operator | NURSE |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARDINAL HEALTH |
| Manufacturer Address | MCGAW PARK IL 60085 US 60085 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-03-10 |