MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2015-06-09 for GOWN ISO POLY-COATED W/THMBHKS UNIV YLW 7211PG manufactured by Cardinal Health Singapore 225 Pte Ltd.
[18896459]
Nurse developed a red raised rash across her chest, neck, and lower jaw line. She was given prednisone and sent to an allergy specialist.
Patient Sequence No: 1, Text Type: D, B5
[19067341]
The customer was unable to provide the lot number or samples. Review of the device history record could not be conducted without the lot number. Historical trending was done. Without the sample, we were not able to conduct an analysis to confirm the reported incident or to identify the root cause. From a review of the current production process, no exception was detected that could lead to the reported incident. The material used for the gown was supplied by an approved source, and passed the biocompatibility tests prescribed by the regulatory agency for the intended use. There was no change in the material composition of the fabric material. The root cause could not be determined. The relevant sectors were informed of the complaint for their reference. No additional action will be taken at this time, but we will continue to monitor complaints for trends of this nature.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1423537-2015-00032 |
| MDR Report Key | 4827561 |
| Report Source | 05 |
| Date Received | 2015-06-09 |
| Date of Report | 2015-06-09 |
| Date of Event | 2015-05-01 |
| Date Mfgr Received | 2015-05-20 |
| Date Added to Maude | 2015-06-09 |
| 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 ISO POLY-COATED W/THMBHKS UNIV YLW |
| Generic Name | NON-SURGICAL ISOLATION GOWN |
| Product Code | OEA |
| Date Received | 2015-06-09 |
| Catalog Number | 7211PG |
| 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 SINGAPORE 225 PTE LTD |
| Manufacturer Address | 10 KALLANG AVENUE SINGAPORE 339510 SN 339510 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-06-09 |