MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-10 for MEDICHOICE INSTANT WARM COMPRESS CWP901 manufactured by Owens & Minor Distribution, Inc..
[141480596]
Hot packs were being prepared to be used on patients. The following 3 incidents in the past month have occurred and the staff brought them to risk management after seeing a possible trend. Unfortunately, only one used packet was saved for any related numbers. No patient harms. Nursing sustained a skin burn. Popped a hot pack tonight to give a patient and it was hot. You could feel the "rocks" in it and i couldn't even hold it, it was so hot. We need to be cautious of them. Rn activated hot pack. The four corners became extremely hot, "unable to touch/handle without getting burned". No staff or patient injury. Hot pack was made ready by this nurse; prior to distributing the pack to a patient, it was noted that the 4 corners of the pack were excessively hot; left a red mark on nurse's hand that resolved with running cold water over the burn. Hot pack was given to manager.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8499752 |
| MDR Report Key | 8499752 |
| Date Received | 2019-04-10 |
| Date of Report | 2019-02-21 |
| Date of Event | 2019-01-25 |
| Report Date | 2019-02-21 |
| Date Reported to FDA | 2019-02-21 |
| Date Reported to Mfgr | 2019-04-10 |
| Date Added to Maude | 2019-04-10 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| 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 | MEDICHOICE INSTANT WARM COMPRESS |
| Generic Name | PACK, HOT OR COLD, REUSABLE |
| Product Code | IME |
| Date Received | 2019-04-10 |
| Model Number | CWP901 |
| Lot Number | 24918/2// |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 0 YR |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | OWENS & MINOR DISTRIBUTION, INC. |
| Manufacturer Address | 9120 LOCKWOOD BOULEVARD MECHANICSVILLE VA 23116 US 23116 |
| Brand Name | MEDICHOICE INSTANT WARM COMPRESS |
| Generic Name | PACK, HOT OR COLD, REUSABLE |
| Product Code | IME |
| Date Received | 2019-04-10 |
| Model Number | CWP901 |
| Lot Number | 24918/2// |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 0 YR |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OWENS & MINOR DISTRIBUTION, INC. |
| Manufacturer Address | 9120 LOCKWOOD BOULEVARD MECHANICSVILLE VA 23116 US 23116 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-04-10 |