MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2007-04-11 for GOWN ISOLATION YELLOW 1100PG manufactured by Cardinal Health.
[557763]
Irritation surrounding gown. Last week 2 employees were sent to our worker's comp. Provider because of symptoms: skin irritations and respiratory difficulty. Both hcp received rx zyrtex medication. The customer mentioned several staff members have a past history of mild sensitivities and allergic reaction issues.
Patient Sequence No: 1, Text Type: D, B5
[7818708]
This is the second complaint of this nature we have received for this catalog number. However, both reports have come from your facility. There have not been any changes to the gown material, which would account for the situation encountered by your nurses. The material used in the product is supplied by an approved supplier. Our factory has not received any allergic complaints from our operators. During the converting process, all operators are required to sterilize their hands every two hours. The environmental controls in our workshops are in compliance with specifications. Furthermore, the converting process (cutting, sewing, folding... Etc. ) in our factory is not likely to cause any type of irritation reaction. No chemical or additive is used in the converting process. During the product development phase, all materials used for the gown were evaluated for biocompatibility. The testing was performed in accordance with internal standard iso10993 biological evaluation of medical devices. Only materials that successfully complete these tests can be commercialized. The tests utilized are designed to predict the safety of the product for the general population of users. Unfortunately, no test or series of tests can guarantee that a particular item will be compatible with all users.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1423507-2007-00035 |
| MDR Report Key | 839037 |
| Report Source | 05,07 |
| Date Received | 2007-04-11 |
| Date of Report | 2007-04-11 |
| Date of Event | 2007-03-12 |
| Date Mfgr Received | 2007-03-13 |
| Date Added to Maude | 2007-04-20 |
| 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 | MCGRAW PARK IL 60085 |
| Manufacturer Country | US |
| Manufacturer Postal | 60085 |
| Manufacturer Phone | 8475786412 |
| Manufacturer G1 | EL PASO - SURGICAL GROUP |
| 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 | 2007-04-11 |
| 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 | 826341 |
| Manufacturer | CARDINAL HEALTH |
| Manufacturer Address | * MCGAW PARK IL * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2007-04-11 |