MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-07-19 for INSTANT HOT PACK, MEDIUM 11450-040 manufactured by Cardinal Health 200, Llc.
[114438177]
Nurse attempted to activate/compress heat pack to apply to skin prior to iv placement in pre-op. Heat pack exploded contents on patient's right forearm and my right upper leg. Cleaned patient's skin with towel and changed my scrub pants. Appeared majority of contents landed on me instead of patient. Assessed patient's skin no discoloration, patient denied contents feeling warm/hot on skin, denied pain.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7702252 |
| MDR Report Key | 7702252 |
| Date Received | 2018-07-19 |
| Date of Report | 2018-07-11 |
| Date of Event | 2018-06-04 |
| Report Date | 2018-07-11 |
| Date Reported to FDA | 2018-07-11 |
| Date Reported to Mfgr | 2018-07-19 |
| Date Added to Maude | 2018-07-19 |
| 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, MEDIUM |
| Generic Name | HEAT PACK |
| Product Code | IMA |
| Date Received | 2018-07-19 |
| Catalog Number | 11450-040 |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARDINAL HEALTH 200, LLC |
| Manufacturer Address | 808 W HIGHWAY 24 MOBERLY MO 65270 US 65270 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-07-19 |