MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-18 for BLUE COMFORT BOUFFANT 24 IN 3274 manufactured by Hubei Safeway Protective Products.
[124310973]
Based on the supplier? S investigation, the device history record review did not indicate any exception that could lead to the reported incident. There was no change in the material composition. One bouffant was returned for visual inspection, there was no abnormality found. Considering the complaint defect category of irritation, the supplier reviewed the raw material and component inspection record and their existing material used for this code 3274, complies to the specification and no exception was detected that could result in this reported issue. The elastic material used for the cap passed bio-compatibility tests required by the regulatory agency for the intended use. Based on the investigation, the root cause could not be determined. The complaint information was provided to the relevant sectors for their awareness. There is no additional action taken at this time, but the supplier will continue to monitor the trend of this type of incident.
Patient Sequence No: 1, Text Type: N, H10
[124310974]
The end user-clinician experienced rash from the elastic on bouffant cap on forehead.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423537-2018-00243 |
| MDR Report Key | 7981447 |
| Date Received | 2018-10-18 |
| Date of Report | 2018-10-18 |
| Date of Event | 2018-09-12 |
| Date Facility Aware | 2018-09-21 |
| Report Date | 2018-09-14 |
| Date Reported to Mfgr | 2018-09-14 |
| Date Mfgr Received | 2018-09-21 |
| Date Added to Maude | 2018-10-18 |
| 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 | PATRICIA TUCKER |
| Manufacturer Street | 3651 BIRCHWOOD DR. |
| Manufacturer City | WAUKEGAN IL 60085 |
| Manufacturer Country | US |
| Manufacturer Postal | 60085 |
| Manufacturer Phone | 8478874151 |
| Manufacturer G1 | HUBEI SAFEWAY PROTECTIVE PRODUCTS |
| Manufacturer Street | NO. 118, PENCHANG AVENUE |
| Manufacturer City | XIANTAO HUBEI 433000 |
| Manufacturer Country | CH |
| Manufacturer Postal Code | 433000 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | BLUE COMFORT BOUFFANT 24 IN |
| Generic Name | CAP, SURGICAL |
| Product Code | FYF |
| Date Received | 2018-10-18 |
| Returned To Mfg | 2018-10-04 |
| Model Number | 3274 |
| Catalog Number | 3274 |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HUBEI SAFEWAY PROTECTIVE PRODUCTS |
| Manufacturer Address | NO. 118, PENCHANG AVENUE XIANTAO HUBEI 433000 CH 433000 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-10-18 |