MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2014-10-22 for PAIN EASE 0386-0008-02/03 manufactured by Gebauer Co..
[5149935]
Patient had adverse reaction that resulted in redness, blistering, and edema, that required treatment and resulted in an open wound on the knee. Patient went to her rheumatologist for a cortisone injection in the knee (has injection every six months). Physician applied pain ease topical anesthesic skin refrigerant to the knee for approx 5 seconds prior to performing the cortisone injection. No adverse event symptoms occurred during or immediately following the injection. Approx 5 hours after the injection, the knee started to have pain at the injection site. The patient applied a topical lidocaine patch to the knee for the injection site pain. Around 24 hours after the injection the patient noted redness, blistering (large and small), and edema covering the entire surface of the knee. Physician treated patient with doxycycline, benadryl, silvadene and solumedrol dose pack. Wound also required debridement. Skin is healing 21 days after injection but center of wound is raw (3 cm x 1 cm).
Patient Sequence No: 1, Text Type: D, B5
[12472712]
The adverse event described in this complaint is not consistent with the adverse reactions associated with gebauer's pain ease and we have no similar complaints. Gebauer can not determine if this adverse event is associated with frostbite or an allergic or not related to our product at all. Typically frostbite would be associated with over spraying the product beyond the instructions for use of 4 to 10 seconds. It is highly unlikely that a single 5 seconds spray of pain ease would result in the serious injury described in this complaint. The adverse event is also not consistent with an allergic reaction based on testing conducted to iso 10993 for intact skin, intact mucous membranes and minor open wounds. Based on this testing, the product is not a dermal irritant or sensitizer. The patient also applied a topical lidocaine patch to the injection site 5 hours after the injection which may have contributed and or caused the adverse event. A review of lidocaine patch labeling identifies that the application site may develop blisters, bruising, dermatitis, edema, papules and petechia which is consistent with the adverse event.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1519179-2014-00002 |
| MDR Report Key | 4199377 |
| Report Source | 04 |
| Date Received | 2014-10-22 |
| Date of Report | 2014-10-21 |
| Date of Event | 2014-09-18 |
| Date Mfgr Received | 2014-09-22 |
| Date Added to Maude | 2014-10-27 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | 4444 E. 153RD ST. |
| Manufacturer City | CLEVELAND OH 44128 |
| Manufacturer Country | US |
| Manufacturer Postal | 44128 |
| Manufacturer Phone | 2165813030 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PAIN EASE |
| Generic Name | TOPICAL ANESTHETIC SKIN REFRIGERANT |
| Product Code | MLY |
| Date Received | 2014-10-22 |
| Model Number | 0386-0008-02/03 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GEBAUER CO. |
| Manufacturer Address | CLEVELAND OH US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-10-22 |