MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2014-05-08 for BLUE BOUFFANT, 24" B24HD manufactured by Cardinal Health.
[19388495]
The device history record was reviewed, and no exception was detected that could have resulted in the reported defect. Historical trending was done, and this is the first reported incident in the past 12 months. The actual bouffant worn was not available. However, samples from the same box were evaluated against raw material and product specification. The bouffants met both raw material and product specification requirements. A review of the samples did not show any abnormality. The material used for the bouffant is polypropylene with calcium carbonate which passed biocompatibility tests prescribed by the regulatory agency for the intended use, and there was no change in the material composition, including elastic and thread. The root cause could not be determined. The complaint information was fedback to the related personnel for awareness. There is no corrective action at this time, but we will continue to monitor complaints for any trends of this nature.
Patient Sequence No: 1, Text Type: N, H10
[19405333]
The patient was having a permanent pacemaker implanted. All patients must wear a head covering. At the conclusion of the implant, the patient had redness and itching on her head. She was given iv benadryl, no other treatment was required.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423537-2014-00015 |
| MDR Report Key | 3799720 |
| Report Source | 05,07 |
| Date Received | 2014-05-08 |
| Date of Report | 2014-05-08 |
| Date of Event | 2014-04-14 |
| Date Mfgr Received | 2014-04-14 |
| Device Manufacturer Date | 2013-11-07 |
| Date Added to Maude | 2014-05-08 |
| 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 | 80 ANSON RD |
| Manufacturer City | SINGAPORE 079907 |
| Manufacturer Country | SN |
| Manufacturer Postal Code | 079907 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BLUE BOUFFANT, 24" |
| Generic Name | CAP, SURGICAL |
| Product Code | FYF |
| Date Received | 2014-05-08 |
| Returned To Mfg | 2014-04-28 |
| Catalog Number | B24HD |
| Lot Number | 13LCB311 |
| Device Expiration Date | 2018-10-31 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARDINAL HEALTH |
| Manufacturer Address | SINGAPORE SN |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-05-08 |