MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-12 for MEDLINE STANDARD COLD PACK manufactured by Medline Industries, Inc..
[183115377]
Patient had a medline standard cold pack on abdomen. Mother noticed gray/brownish liquid on the wash cloth that the cold pack was resting on and immediately alerted rn. Rn immediately removed cold pack and soiled linens. Ensured no contents leaked onto patient's skin. Noticed tiny pin-like hole where cold pack contents were leaking; alerted charge nurse, nurse manager and other staff about potential issue with item. Suggestion to check integrity of all heat/cold packs before patient use. Rn noted in safety event reporting system report that similar incident occurred day before when after activated by nurse, product exploded on nurse, wall and floor.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9823754 |
| MDR Report Key | 9823754 |
| Date Received | 2020-03-12 |
| Date of Report | 2020-02-28 |
| Date of Event | 2020-01-30 |
| Report Date | 2020-02-28 |
| Date Reported to FDA | 2020-02-28 |
| Date Reported to Mfgr | 2020-03-12 |
| Date Added to Maude | 2020-03-12 |
| 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 | MEDLINE STANDARD COLD PACK |
| Generic Name | PACK, HOT OR COLD, DISPOSABLE |
| Product Code | IMD |
| Date Received | 2020-03-12 |
| Lot Number | RA19196CAN |
| Operator | LAY USER/PATIENT |
| 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 | 2020-03-12 |