MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2014-01-29 for NOVAPLUS BOUFFANT CAP - SPUNBOND, BLUE, LARGE 69805 manufactured by Kimberly-clark Health Care.
[4069388]
Kimberly-clark received a report stating,? Two people at the facility, a nurse and a patient, had severe reactions to the elastic on the bouffant cap. The nurse broke out in a severe reaction around where the elastic made contact with her skin and the patient had an anaphylactic reaction. The nurse removed the bouffant and no longer wears it, she wears a cloth cap. The patient experienced blistering around the face where the elastic band made contact with the skin and caused difficulty breathing. The bouffant cap was removed and the patient was given iv benadryl. " kimberly-clark has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred. This product incident is documented in the kimberly-clark complaint database and identified as (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[11541490]
The review of the device history record determined that the device was manufactured according to established manufacturing procedures using the correct qualified materials, including the elastic component, and met all specifications. The operators who manufactured the referenced product lot did not report any reaction to the component materials or final product. Additionally, there have been no other reports of an untoward user reaction to the device and lot referenced in this reported event. The device was not returned to kimberly-clark for analysis; therefore, the device could not be analyzed and root cause for the reported incident could not be determined. Information from this incident will be included in our product complaint and mdr trend reporting systems. Ongoing analysis of trend information is used to identify the need for additional investigations.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1033422-2014-00002 |
| MDR Report Key | 3596204 |
| Report Source | 07 |
| Date Received | 2014-01-29 |
| Date of Report | 2013-12-30 |
| Date Mfgr Received | 2013-12-30 |
| Date Added to Maude | 2014-01-29 |
| 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 |
| Reporter Occupation | MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | MR RA/QA AE COORDINATOR |
| Manufacturer Street | 1400 HOLCOMB BRIDGE RD BLDG 200 |
| Manufacturer City | ROSWELL GA 30076 |
| Manufacturer Country | US |
| Manufacturer Postal | 30076 |
| Manufacturer Phone | 7705877200 |
| Manufacturer G1 | MASTERS AND FRANK |
| Manufacturer Street | NO. 128 INDUSTRIAL PARK DONG GUAN CITY |
| Manufacturer Country | CH |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NOVAPLUS BOUFFANT CAP - SPUNBOND, BLUE, LARGE |
| Product Code | FYF |
| Date Received | 2014-01-29 |
| Catalog Number | 69805 |
| Lot Number | 0160934001 |
| Operator | NURSE |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KIMBERLY-CLARK HEALTH CARE |
| Manufacturer Address | 1400 HOLCOMB BRIDGE RD BLDG 200 ROSWELL GA 30076 US 30076 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-01-29 |