MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-07-29 for BLUE COMFORT BOUFFANT 24 IN 3274 manufactured by Cardinal Health.
[23155288]
Multiple attempts to obtain samples from the customer were made and the samples have just been received. Therefore; a follow up report will be filed once the sample evaluation has been completed.
Patient Sequence No: 1, Text Type: N, H10
[23155289]
The patient has allergy conditions and developed a rash around her hairline where the cap fit. Caps are latex free.
Patient Sequence No: 1, Text Type: D, B5
[34205919]
The customer's sample was received for evaluation. A review of the returned sample did not indicate any abnormal findings that would result in the allergic reaction. A review of the device history record could not be conducted as no lot number was provided. A review of raw material records for the current production indicated that the material used was approved and in compliance with the required specifications. The material used for the bouffant is polypropylene with calcium carbonate fillers, which passed the biocompatibility tests prescribed by the regulatory agency for the intended use. There were no changes to the material composition including elastic and thread. Therefore, based on these findings we are unable to determine the root cause for the issue reported. No corrective action will be taken at this time. We will continue to monitor for any similar reports.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1423537-2015-00055 |
| MDR Report Key | 4950675 |
| Date Received | 2015-07-29 |
| Date of Report | 2015-07-29 |
| Date of Event | 2015-06-29 |
| Date Mfgr Received | 2015-06-30 |
| Date Added to Maude | 2015-07-29 |
| 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 #10-10/18 APERIA |
| 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 | BLUE COMFORT BOUFFANT 24 IN |
| Generic Name | BLUE COMFORT BOUFFANT |
| Product Code | FYF |
| Date Received | 2015-07-29 |
| Returned To Mfg | 2015-07-27 |
| Model Number | 3274 |
| Catalog Number | 3274 |
| Lot Number | NO LOT GIVEN |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARDINAL HEALTH |
| Manufacturer Address | 1500 WAUKEGAN ROAD WAUKEGAN IL 60085 US 60085 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-07-29 |