MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-11 for INSTANT HOT PACK MDS139008 manufactured by Medline Industries, Inc.
[182964465]
Medline instant hot pack exploded when activated over rn, patient and patient family member. Rn notified charge nurse and safety immediately. Hot pack material/particles exploded onto the patient's bed, clothing and skin; on clothing and skin of rn; and on clothing and skin of patient family member. Family member washed exposed skin and patient was moved to another bed and bed linen replaced. Rn unsure of skin exposure but washed hands and upper arms and changed into new scrubs. Particles of hot pack also exploded onto floor and furniture throughout the room which was cleaned by environmental services. Staff member was informed of immediate risk mitigation and submitted an accident report to occupational health service. (b)(6) will meet with patient and family to offer shower/clothing to change into. Email notification to environmental health and safety, supply chain products taken for immediate review. Review of maude database and outreach to medsun.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9817648 |
| MDR Report Key | 9817648 |
| Date Received | 2020-03-11 |
| Date of Report | 2020-02-28 |
| Date of Event | 2020-02-25 |
| Report Date | 2020-02-28 |
| Date Reported to FDA | 2020-02-28 |
| Date Reported to Mfgr | 2020-03-11 |
| Date Added to Maude | 2020-03-11 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INSTANT HOT PACK |
| Generic Name | PACK, HOT OR COLD, DISPOSABLE |
| Product Code | IMD |
| Date Received | 2020-03-11 |
| Catalog Number | MDS139008 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | 1 DA |
| Device Eval'ed by Mfgr | * |
| 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 | 2020-03-11 |