FDA Logo links to FDA home pageCenter for Devices and Radiological Health, U.S. Food and Drug AdministrationHHS Logo links to Department of Health and Human Services website

FDA Home Page | CDRH Home Page | Search | CDRH A-Z Index | Contact CDRH U.S. Food and Drug Administration Center for Devices and Radiological Health [Skip navigation]
horizonal rule
Super Search
510(k) | Registration & Listing | Adverse Events | PMA | Classification | CLIA
CFR Title 21 | Advisory Committees | Assembler | Recalls | Guidance | Standards
 

 

Adverse Event Report

DEVON INDUSTRIES ANDREWS TABLE FOAM HEADREST   back to search results
Model Number C-30031
Event Date 02/12/1996
Patient Outcome  Required Intervention;
Event Description

In mid-february, surgery techs noted 4-5 surgical lumbar pts with skin reactions following use of certain foam headrests, which are part of a pre-packaged surgical kit. Over the previous 2-3 weeks, techs had noticed that the newer headrests were not the original color. The color had gradually been changing from pale pink to deep fuschia. The skin reactions were noted to occur only with the darker headrests. The darker the color, the more severe the reaction. The sales rep was notified by phone on 2/14/96 of the problem and asked to pick-up all fuschia headrests and replace them with the original pink one. The pts with skin reactions were assessed in the or, in pacu and again in their rooms. All the rashes appeared to be resolving without treatment, so no other follow-up was done unil 3/6/96; when the surgeon for the referenced pt reported that the pt's rash had deepened. He referred the pt to a dermatologist for add'l treatment.

 
Search Alerts/Recalls

  new search  |  submit an adverse event report

Brand NameANDREWS TABLE FOAM HEADREST
Type of DeviceFOAM HEADREST
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section F)
DEVON INDUSTRIES
9530 desoto ave
chatsworth CA 91311
Manufacturer (Section D)
DEVON INDUSTRIES
9530 desoto ave
chatsworth CA 91311
Device Event Key34669
MDR Report Key33329
Event Key31314
Report Number33329
Device Sequence Number1
Product CodeBWN
Report Source User Facility
Reporter Occupation RISK MANAGER
Type of Report Initial
Report Date 03/14/1996
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/15/1996
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device MODEL NumberC-30031
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/14/1996
Distributor Facility Aware Date03/07/1996
Device Ageno info
Event Location Hospital
Date Report TO Manufacturer03/14/1996
Is the Device an Implant? No
Is this an Explanted Device?

Database last updated on January 30, 2009

horizonal rule

CDRH Home Page | CDRH A-Z Index | Contact CDRH | Accessibility | Disclaimer
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | HHS Home Page

Center for Devices and Radiological Health / CDRH