• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services


  • Print
  • Share
  • E-mail
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC

Lot Number RX#173247142459
Device Problems Patient-Device Incompatibility (2682); Appropriate Term/Code Not Available (3191)
Patient Problems Bruise/Contusion (1754); Itching Sensation (1943); Pain (1994); Rash (2033); Discomfort (2330); Reaction (2414); Irritability (2421); Ambulation Difficulties (2544)
Event Date 12/08/2017
Event Type  Injury  
Event Description
(b)(6) (approx) - received lupron depot - ped 3mth pfl kit strength: 30mg provided by (b)(6) (received approx. (b)(6) and son brought inside right away). Rx # (b)(6). Shot was stored on kitchen counter away for appliances at temps ranging from 70 - 74 degrees. (b)(6) at 1500 hours - at (b)(6) hospital (b)(6) received lupron injection in one of the quads towards the center of right leg. Paying most attention to daughter needs from crying and pain. Recalling the needle was in as deep as needle could go and the injection took several seconds to inject pausing several times and waiting maybe 10 seconds to inject. Maybe 3 pauses. Almost instantly (b)(6) stated she was itching bad above knee where it appeared to be a small bruise. Picture was taken after rash started going away. Both father and doctor took photos. Within approx. 20 seconds, bruise type rash covered from knee to just below the hip. Nurse left room and more nurses and doctors came in the room (approx. 6 combined). Dr. (b)(6) stated within 30 minutes of inject no more lupron injects and stated he was going to report it to the company and i should report it as well. (b)(6) was given an ice pack and benadryl. The rash started to go away even more within the 30 minutes time. After taking (b)(6) up and down the hall limping (not moving knee) for approx. 20 minutes and monitoring, we were released approx. 1700 hrs with (b)(6) still limping and with rash covering a large part of her upper leg. Instructed her to get rest over the weekend and go to the nearest er with any difficulty breathing or any other concerns. On the way home from hospital (approx. 1:10 hours travel time), nurse called wife at home to tell her to pick-up steroid prednisone 20mg (3 tab once a day) from (b)(6) pharmacy. (b)(6) took tab at 2000 hours as directed. On (b)(6) at 2200 hours - (b)(6) started having some of the rare but serious side effects listed on fact sheet (unusual sensation in back and leg/ not using knee/muscle weakness/loss of use. Took her to the (b)(6) emergency room. She was pacing back and forth with a lump in an anger/irritable mood. Dr. (b)(6) said there's not much they can do. Her pain in leg is getting a little better with ibuprofen. Released and told to get with prescribing doctor on monday. She paced all night scared, angry, irritable, and unable to get comfortable and extremely tired getting no rest until 0800 hrs on (b)(6). (b)(6) at approx. 1900 hrs i called the on-call endocrinologist (dr. (b)(6) - not exact spelling). He said she didn't have to take it and continue with the benadryl. (b)(6) at 0600 hrs (b)(6) woke up with a bad stomachache and headache. At 1000 hours text on-call dr. (b)(6) that my daughter still can't walk or bend knee. If you still have concerns or she still can't bend knee go to the er. He instructed her to take a hot bath and try to bend. She was unable to bend knee. When we told my daughter we need to go to the er, she went on an angry rage refusing to go for 30 minutes. This is unusual behavior. Dr. (b)(6) at (b)(6) er was very concerned and stated he needed to get some professional advice from the on-call endocrinologist dr. (b)(6) and a pediatrics ortho dr. (b)(6) ((b)(6) hospital). This was lots of coordinating and research and work to get in contact and receive advice from these doctors. Concerns of compartmental syndrome an ultrasound and blood test was taken. Based on the results released with appointment at 0800 hrs in the morning at (b)(6) with dr. (b)(6). (b)(6) at 0800 hrs seen by dr. (b)(6) at the ortho office at (b)(6). Dr. Took more in-depth ultrasound and diagnosed with inflammation of the muscle/secondary reaction from the medicine. Dr. Said pain and leg use should be getting better within the week and she should try and start bending and walking when she can. If she can't use her leg in a week, then call the office for a follow-up or referred to pt. Dose or amount: 1 injection. Frequency: 3 months. Route: given into/ under the skin. Dates of use: (b)(6) 2017. Diagnosis or reason for use: growth to potential height.
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

MDR Report Key7116633
MDR Text Key95077613
Report NumberMW5073967
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Unknown
Type of Report Initial
Report Date 12/12/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/13/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Lot NumberRX#173247142459
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 12/13/2017 Patient Sequence Number: 1