MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2004-10-15 for GOWN ISOLATION YELLOW 1100PG manufactured by Cardinal Health.
[21614543]
Itching and skin reaction once donning gown. Female rn, staff member stated they experienced a skin irritation, wheezing and shortness of breath from either the non-latex cardinal health isolation gown or the latex gloves they were wearing (manufacturer unknown) at time of incident. Per rn they have seen a dermatologist and has a follow-up appointment in 10/2004. Theywere immediately given an epi-steroid injection for wheezing and shortness of breath and later prescribed cortisone cream for the skin irritation. Rn reports no lost time from work.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423507-2004-00097 |
| MDR Report Key | 549107 |
| Report Source | 05,07 |
| Date Received | 2004-10-15 |
| Date of Report | 2004-10-15 |
| Date of Event | 2004-09-27 |
| Date Mfgr Received | 2004-09-29 |
| Device Manufacturer Date | 2001-07-01 |
| Date Added to Maude | 2004-10-19 |
| 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 | 0 |
| Manufacturer Contact | MICHELE DONATICH |
| Manufacturer Street | 1430 WAUKEGAN RD, BLDG KB |
| Manufacturer City | MCGAW PARK IL 60085 |
| Manufacturer Country | US |
| Manufacturer Postal | 60085 |
| Manufacturer Phone | 8475786412 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GOWN ISOLATION YELLOW |
| Generic Name | GOWN ISOLATION YELLOW |
| Product Code | FYC |
| Date Received | 2004-10-15 |
| Model Number | 1100PG |
| Catalog Number | 1100PG |
| Lot Number | UNK |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 538596 |
| Manufacturer | CARDINAL HEALTH |
| Manufacturer Address | . MCGAW PARK IL * US |
| Baseline Brand Name | GOWN ISOLATION YELLOW |
| Baseline Generic Name | GOWN ISOLATION YELLOW |
| Baseline Model No | 1100PG |
| Baseline Catalog No | 1100PG |
| Baseline Device Family | APPAREL |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K851823 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2004-10-15 |