MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2020-03-10 for MDS139005 manufactured by Medline Industries Inc..
[186543544]
It was reported that the hot pack burst during activation. Reportedly, the hot pack was activated by "squeezing. " the hot pack contents made contact with a staff member's right forearm and the contact site was flushed with cold water. The staff member went to the reporting facility's emergency department (ed) after the incident where the contact site was flushed with cold water for an additional 15 minutes, the contact site was treated with bacitracin, and a dressing was applied. The staff member was discharged from the ed with a diagnosis of a 2nd degree burn to the right forearm and was prescribed tylenol and percocet for pain control. No additional medical intervention or follow-up care was reported to the manufacturer. A sample was returned to the manufacturer for evaluation. The sample was noted to be have a tear at the bottom of the pouch. The root cause has been attributed to use error. It was indicated that the hot pack was activated by "squeezing. " users are instructed to activate the hot pack by folding the pouch. Due to the reported diagnosis of a 2nd degree burn and the need for medical intervention, 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
[186543545]
It was reported that the hot pack burst during activation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1417592-2020-00016 |
| MDR Report Key | 9811780 |
| Report Source | USER FACILITY |
| Date Received | 2020-03-10 |
| Date of Report | 2020-03-10 |
| Date of Event | 2020-02-12 |
| Date Mfgr Received | 2020-02-12 |
| Date Added to Maude | 2020-03-10 |
| 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 | NIGEL VILCHES |
| Manufacturer Street | THREE LAKES DRIVE |
| Manufacturer City | NORTHFIELD, IL |
| Manufacturer Country | US |
| Manufacturer Phone | 9311458 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | PACK,HOT,INSTANT,INSULATED,6"X10" |
| Product Code | IMD |
| Date Received | 2020-03-10 |
| Returned To Mfg | 2020-02-28 |
| Catalog Number | MDS139005 |
| Lot Number | VN19276 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES INC. |
| Manufacturer Address | THREE LAKES DRIVE NORTHFIELD, IL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2020-03-10 |