MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-02-29 for GOWN ISO POLY-COATED W/KNITCUFF UNIV WHT 7300PG manufactured by Cardinal Health Singapore 225 Pte Ltd.
[39641038]
(b)(4). The device history record for lot number 15dfy110 did not indicate any exception that could lead to the reported incident. Indicated no abnormal event was detected. This lot number was made in may of 2015. There was no deviation for the raw material, accessories, production equipment, process and environment. The main materials such as cuff and spp/laminated materials for body materials had been subjected to and passed the biocompatibility test prescribed for the intended use of the products. Review of the samples provided confirmed no differences between the returned samples with the production products. This was the first reported incident for 7300pg. From this investigation, the reported problem could not be confirmed and the root cause could not be determined.
Patient Sequence No: 1, Text Type: N, H10
[39641039]
We are seeing dermatitis when using the white gown.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423537-2016-00009 |
| MDR Report Key | 5467836 |
| Date Received | 2016-02-29 |
| Date of Report | 2016-02-29 |
| Date of Event | 2016-02-08 |
| Date Mfgr Received | 2016-02-08 |
| Date Added to Maude | 2016-02-29 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| 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 | 0 |
| Brand Name | GOWN ISO POLY-COATED W/KNITCUFF UNIV WHT |
| Generic Name | GOWN ISO POLY-COATED W/KNITCUFF UNIV WHT |
| Product Code | OEA |
| Date Received | 2016-02-29 |
| Model Number | 7300PG |
| Catalog Number | 7300PG |
| Lot Number | 15DFY110 |
| Operator | NURSE |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARDINAL HEALTH SINGAPORE 225 PTE LTD |
| Manufacturer Address | SINGAPORE SN |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-02-29 |