MAUDE Adverse Event Report: KIMBERLY-CLARK HEALTH CARE NOVAPLUS BOUFFANT CAP - SPUNBOND, BLUE, LARGE

Catalog Number 69805

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hypersensitivity/Allergic reaction (1907); Respiratory Distress (2045); Swelling (2091); Reaction (2414)

Event Type  Injury  

Event Description

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).

Manufacturer Narrative

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.

• Brand Name: NOVAPLUS BOUFFANT CAP - SPUNBOND, BLUE, LARGE
• Manufacturer (Section D): KIMBERLY-CLARK HEALTH CARE; 1400 holcomb bridge rd; bldg 200; roswell GA 30076
• Manufacturer (Section G): MASTERS AND FRANK; no. 128 industrial park; dong guan city; CH
• Manufacturer Contact: ra/qa ae coordinator ; 1400 holcomb bridge rd; bldg 200; roswell, GA 30076 ; 7705877200
• MDR Report Key: 3596204
• MDR Text Key: 4069388
• Report Number: 1033422-2014-00002
• Device Sequence Number: 1
• Product Code: FYF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 12/30/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Nurse
• Device Catalogue Number: 69805
• Device Lot Number: 0160934001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/30/2013
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 31 YR
• Patient Weight: 77