MAUDE Adverse Event Report: STRYKER PUERTO RICO, LLC. STRYKER CEMENT; CEMENT, BONE, VERTEBROPLASTY

Patient Problems Hypersensitivity/Allergic reaction (1907); Rash (2033)

Event Date 01/29/2023

Event Type  Injury  

Event Description

During (b)(6) of 2023, my mother, (b)(6), had a procedure performed by the (b)(6) spine center in (b)(6).After the procedure, my mother had a rash that broke out all over her body.Intense itching started over her whole body.I have pictures of her rash, that showed up well in her legs and back.The procedure she had done, was where the dr put what they call plastic, which is really some kind of cement, used to fill in a fracture in her t11 vertebrae.After the procedure is when this happened.Stryker is the name of the company that supplies the cement.Have tried to get a sample of it, and the dr has also, and they will not play ball.My thoughts are that if we can get a sample of it, i can have a dermatologist or allergist, perform a skin test or score test to see if my mother is allergic to this.They absolutely will not give a sample to me.When talking with one of their engineer's via e-mail.He said that they only supply to their customers.Well, the dr couldn't get the sample also.Please help us! this company actions makes you think they have something to hide! my phone number is (b)(6), and my name is (b)(6).I'm the caregiver for my mother.

• Brand Name: STRYKER CEMENT
• Type of Device: CEMENT, BONE, VERTEBROPLASTY
• Manufacturer (Section D): STRYKER PUERTO RICO, LLC.
• MDR Report Key: 17781569
• MDR Text Key: 323924456
• Report Number: MW5145912
• Device Sequence Number: 1
• Product Code: NDN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 09/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Treatment: ACETAMINOPHEN.; ALBUTEROL SULFATE.; APIXABAN.; BENEFIBER.; CALTEC.; CLARITIN GEL.; CLOPIDOGREL.; COQ10.; FERROUS FUMARATE.; FLUTICASONE PROPION-SALMETEROL.; GABAPENTIN.; METHOCARBAMOL.; METOPROLOL TARTRATE.; MIRALAX.; MONTELUKAST.; MUCINEX.; PANTOPRAZOLE.; PEPTO-BISMOL.; PROBIOTIC.; SUCRALFATE.; VITAMIN C.; XX VITAMINS.
• Patient Outcome(s): Other
• Patient Age: 91 YR
• Patient Sex: Female
• Patient Weight: 57 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White