MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2015-10-15 for PAIN EASE 0386-0008-03 manufactured by Gebauer Company.
[28435567]
Based on the test results that indicate that the device meets the requirements for composition and purity, there appears to be no product malfunction or defect. Also, based on the amount of product left in the can, the product was most likely used on other patients with no adverse reaction. The most likely causes of the problem may be frostbite due to over spraying, the diabetic condition of patient or nothing to do with device. The reporter indicates spraying the product in accordance with instructions for use but this can't be confirmed. Previous product complaints for frostbite have been associated with over spraying. Assuming the product was applied correctly the diabetic condition of the patient may have caused the adverse reaction to the product. Both over spraying and not using the product on persons with poor circulation are addressed on the product's instructions for use. Other products were applied to the patient during the procedure which also could have caused the adverse reaction.
Patient Sequence No: 1, Text Type: N, H10
[28435568]
The patient (male) was being treated by the initial reporter for ingrown toe nail removal. The patient had pain ease applied to the 5th digit of the right foot prior to the ingrown toe nail removal procedure on (b)(6) 2015. The reporter identified that pain ease was applied for approximately 5 seconds from 2 to 3 inches away from the 5th digit in accordance with the product's instructions for use. Pain ease was applied as a topical anesthetic prior to the minor surgical procedure. The patient is a diabetic. The reporter does not believe that pain ease was previously used on the patient. The reporter did not note any adverse reaction at the time of the procedure. In addition to using pain ease, fudes spray, 70% rubbing alcohol and polysporin were applied to the affected toe. The patient went to the emergency department 5 days after the ingrown toe nail removal procedure ((b)(6) 2015). The toe that had the procedure performed on it had broken skin/broken blister(s) with redness and swelling. As described, the patient was experiencing significant pain and having difficulty walking. The emergency department treated the patient with an antibiotic dressing and required the patient to return for frequent dressing changes.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1519179-2015-00002 |
| MDR Report Key | 5154237 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2015-10-15 |
| Date of Report | 2015-10-15 |
| Date of Event | 2015-09-16 |
| Date Mfgr Received | 2015-09-23 |
| Device Manufacturer Date | 2015-12-08 |
| Date Added to Maude | 2015-10-15 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. AMY PAUKOVITS |
| Manufacturer Street | 4444 EAST 153RD STREET |
| Manufacturer City | CLEVELAND OH 441282955 |
| Manufacturer Country | US |
| Manufacturer Postal | 441282955 |
| Manufacturer Phone | 2165813030 |
| Manufacturer G1 | GEBAUER COMPANY |
| Manufacturer Street | 4444 EAST 153RD STREET |
| Manufacturer City | CLEVELAND OH 441282955 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 441282955 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PAIN EASE |
| Generic Name | TOPICAL ANESTHETIC SKIN REFRIGERANT |
| Product Code | MLY |
| Date Received | 2015-10-15 |
| Returned To Mfg | 2015-10-02 |
| Model Number | 0386-0008-03 |
| Lot Number | 6337 |
| Device Expiration Date | 2016-12-31 |
| Operator | NURSE |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GEBAUER COMPANY |
| Manufacturer Address | 4444 EAST 153RD STREET CLEVELAND OH 441282955 US 441282955 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-10-15 |