MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-07-02 for INSTANT HOT PACK 11443-512 manufactured by Cardinal Health 200, Llc.
[112890014]
Instant hot pack activated and contents spilled to floor after activation. No contents reached patient; area immediately cleaned by rn. Seam at top of pouch separated when product was squeezed during attempted activation. No other punctures or tears noted on pouch.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7654275 |
| MDR Report Key | 7654275 |
| Date Received | 2018-07-02 |
| Date of Report | 2018-06-29 |
| Date of Event | 2018-06-28 |
| Report Date | 2018-06-29 |
| Date Reported to FDA | 2018-06-29 |
| Date Reported to Mfgr | 2018-07-02 |
| Date Added to Maude | 2018-07-02 |
| 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 | INSTANT HOT PACK |
| Product Code | IME |
| Date Received | 2018-07-02 |
| Model Number | 11443-512 |
| Catalog Number | 11443-512 |
| Lot Number | V8H054 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 1 DA |
| 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 | 2018-07-02 |