SURGIGRIP LATEX-FREE SIZE F - 4" X 10 METERS
Received Jun 11, 2021
Report 9680091-2021-00008 · MDR key 11987165
Device
Product problems
- Appropriate Device Problem Term/Code Not Available
- Appropriate Device Problem Term/Code Not Available
Patient
Not reported
- Hypersensitivity/Allergic reaction
- Hypersensitivity/Allergic reaction
Narrative
Additional Manufacturer Narrative
AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.
Description of Event or Problem
A FACILITY REPORTED THAT THE PATIENT HAD AN ALLERGIC REACTION TO THE PRODUCT EVEN THOUGH IT SAYS LATEX FREE ON THE BOX. THE USER CLAIMS HER LEGS TURNED RED AND STARTED TO SWELL AFTER HAVING THIS ON ONLY FOR ABOUT AN HOUR AND HER SKIN WAS IRRITATED FOR A WHILE. SHE DOES HAVE AN ALLERGY TO LATEX. THE PRODUCT WAS USED FOR COMPRESSION ON LEGS.
Additional Manufacturer Narrative
THE SURGIGRIP LATEX-FREE WAS NOT RETURNED FOR EVALUATION AND LOT NUMBER INFORMATION HAS NOT BEEN PROVIDED; THEREFORE, AN EVALUATION OF THE DEVICE COULD NOT BE PERFORMED, AND MANUFACTURING RECORDS COULD NOT BE REVIEWED. THE CAUSE(S) OF THE DIFFICULTY REPORTED BY THE CUSTOMER COULD NOT BE DETERMINED. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE IN THE FUTURE, THIS COMPLAINT WILL BE REOPENED, AND THE RESPECTIVE EVALUATION PERFORMED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR ISSUES. AT PRESENT, WE CONSIDER THIS COMPLAINT TO BE CLOSED.
Description of Event or Problem
N/A.