MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2015-04-02 for GOWN ISOLATION AAMI 2 W/TIES XL YLW AT4450-XL manufactured by Cardinal Health Singapore 225 Pte Ltd.
[5733146]
Nurse experienced skin irritation/discomfort on wrists and arms. Went to the ed on the night shift where she received prescriptive creams and steroids to assist with the treatment of the inflammation. No additional information.
Patient Sequence No: 1, Text Type: D, B5
[13181292]
The device history record was reviewed, and no exceptions were noted. Historical trending was done and this was the first reported incidence of skin irritation for this product. The sample was received and a visual inspection showed no abnormality. The material used for the gown sleeve and the wrist elastic passed the biocompatibility test prescribed by regulatory agency for the intended use. There was no change in the material composition of the fabric materials and the elastic. The root cause could not be determined. The complaint information was shared with the relevant sectors for their reference. There is no additional action to be taken at this time, but we will continue to monitor for trends of this nature.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1423537-2015-00017 |
| MDR Report Key | 4653485 |
| Report Source | 05,07 |
| Date Received | 2015-04-02 |
| Date of Report | 2015-04-02 |
| Date of Event | 2015-02-12 |
| Date Mfgr Received | 2015-03-13 |
| Device Manufacturer Date | 2014-03-24 |
| Date Added to Maude | 2015-04-02 |
| 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 | 1500 WAUKEGAN ROAD |
| Manufacturer City | WAUKEGAN IL 60085 |
| Manufacturer Country | US |
| Manufacturer Postal | 60085 |
| Manufacturer Phone | 8478876412 |
| Manufacturer G1 | CARDINAL HEALTH SINGAPORE 225 PTE LTD |
| Manufacturer Street | 10 KALLANG AVENUE |
| Manufacturer City | SINGAPORE 339510 |
| Manufacturer Country | SN |
| Manufacturer Postal Code | 339510 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GOWN ISOLATION AAMI 2 W/TIES XL YLW |
| Generic Name | NON-SURGICAL ISOLATION GOWN |
| Product Code | OEA |
| Date Received | 2015-04-02 |
| Returned To Mfg | 2015-02-25 |
| Catalog Number | AT4450-XL |
| Lot Number | 14CCL077 |
| Operator | NURSE |
| Device Availability | R |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARDINAL HEALTH SINGAPORE 225 PTE LTD |
| Manufacturer Address | 10 KALLANG AVENUE SINGAPORE 339510 SN 339510 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-04-02 |