MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2012-03-26 for GOWN PLASTIC FILM IMPERVIOUS 5210PG manufactured by Cardinal Health.
[18275444]
The nurse, after wearing the gown, noted a rash on her neck and left side of face. Scattered blotchy areas were noted on her arms along with itching. Two hours after the initial reaction, she developed more extensive hives and wheezing. She went to the emergency room where she received iv benadryl, iv solu-medrol, and iv pepcid. Upon discharge, she was given prescriptions for atarax, pepcid, and prednisone. She also had an episode where she brushed up against someone wearing the gown, and developed hives at the site. The nurse has been sent to employee health for further evaluation, and may be seeing an allergist.
Patient Sequence No: 1, Text Type: D, B5
[18519322]
The customer was not able to provide the lot number, therefore, the device history record could not be reviewed. Historical trending was done. The customer also was not able to provide the sample. Since there was no lot number or sample available, an investigation could not be conducted to determine if there was any deviation that could have led to this complaint. The root cause could not be determined. This product is made of (b)(4), and has passed a series of tests prescribed by regulatory agencies for the intended use. However, the possibility of some individual experiencing a reaction can not be ruled out. Relevant production personnel were informed of the complaint. We will continue to monitor complaints for any such issues.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1423537-2012-00012 |
| MDR Report Key | 2503625 |
| Report Source | 05,07 |
| Date Received | 2012-03-26 |
| Date of Report | 2012-03-26 |
| Date of Event | 2012-01-28 |
| Date Mfgr Received | 2012-03-07 |
| Date Added to Maude | 2012-03-26 |
| 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 | 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 | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GOWN PLASTIC FILM IMPERVIOUS |
| Generic Name | GOWN, EXAMINATION |
| Product Code | FME |
| Date Received | 2012-03-26 |
| Catalog Number | 5210PG |
| Lot Number | UNKNOWN |
| 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 | 2012-03-26 |