MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2018-06-11 for FMD959 manufactured by Medline Industries Inc..
[110703480]
It was reported that the end-user, who has history of unspecified cancer and has neuropathy in her right arm and left leg, initiated use of cold therapy as instructed by her pain doctor. End-user stated she put the cold pack in the freezer and pulled it out the next day to apply on her arm. Per report, the end-user put the cold pack into a sock and put the pack on her right arm for approximately 10-12 minutes before she noticed the area started to looked red and felt like it was burning. There was no intervention performed at this time. The end-user reportedly went to her pharmacy to pick up her routine prescriptions and an employee at the pharmacy told her that there were blisters on her right arm and instructed her to go to the emergency room for evaluation. It was reported that the end-user went to the emergency room, was informed that she had a second degree burn and was instructed to use sulfadiazine 1% to the affected area for 5 days and cover with gauze. Shortly after the emergency room visit, end-user had a regular follow up appointment with her doctor and was instructed to use aloe on the area. Per report, the area is healing well and end-user continues to use aloe to help with healing. No further medical intervention was required. The sample was discarded and is not available to be returned for evaluation. A root cause has not been determined at this time. No additional information is available. Due to the reported incident, this medwatch is being filed. If additional relevant information becomes available, a supplemental medwatch will be filed.
Patient Sequence No: 1, Text Type: N, H10
[110703481]
It was reported that end-user had partial thickness burn of the right upper arm from using re-usable cold therapy bag.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1417592-2018-00056 |
| MDR Report Key | 7588939 |
| Report Source | CONSUMER |
| Date Received | 2018-06-11 |
| Date of Report | 2018-06-11 |
| Date of Event | 2018-05-24 |
| Date Mfgr Received | 2018-06-05 |
| Date Added to Maude | 2018-06-11 |
| 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 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | BERMON PUNZALAN |
| Manufacturer Street | THREE LAKES DRIVE |
| Manufacturer City | NORTHFIELD IL 60093 |
| Manufacturer Country | US |
| Manufacturer Postal | 60093 |
| Manufacturer Phone | 2249311514 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | PACK,HOT/COLD,REUSABLE,FAMLY DOLLR SKU |
| Product Code | IME |
| Date Received | 2018-06-11 |
| Catalog Number | FMD959 |
| Lot Number | UNK |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES INC. |
| Manufacturer Address | THREE LAKES DRIVE NORTHFIELD IL 60093 US 60093 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-06-11 |