MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-10-23 for BLUE COMFORT BOUFFANT 24 IN 3274 manufactured by Cardinal Health Singapore 225 Pte Ltd.
[29405786]
(b)(4). The device history report review did not indicate any exception that could lead to the reported incident. Review of the raw materials indicated that the materials, including the main fabrics and elastics, were from approved source which had been subjected to the biocompatibility tests for the intended use. There were no records of changes to the material composition and process that could lead to the reported incident. Review of the returned samples confirmed that the materials used were consistent with our existing production materials and therefore met product specifications. From the investigation, the root cause could not be determined.
Patient Sequence No: 1, Text Type: N, H10
[29405787]
A registered nurse complained of itchiness- possible allergy.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423537-2015-00069 |
| MDR Report Key | 5171579 |
| Date Received | 2015-10-23 |
| Date of Report | 2015-10-22 |
| Date of Event | 2015-09-29 |
| Date Mfgr Received | 2015-09-29 |
| Date Added to Maude | 2015-10-23 |
| 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 | 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 | BLUE COMFORT BOUFFANT 24 IN |
| Generic Name | BLUE COMFORT BOUFFANT 24 IN |
| Product Code | FYF |
| Date Received | 2015-10-23 |
| Returned To Mfg | 2015-10-13 |
| Model Number | 3274 |
| Catalog Number | 3274 |
| Lot Number | 15EFB131 |
| 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 | 2015-10-23 |