MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-19 for MDS148010 manufactured by Medline Industries Inc..
[186543658]
It was reported by the facility that a cold pack leaked and a child ingested the contents of a cold pack. Per the facility nurse, the cold pack was activated by the nurse by squeezing the cold pack in the center between two hands prior to being applied to the child's forehead. Reportedly, after the cold pack was applied to the child's forehead the contents of the cold pack leaked at the seam onto the child's face and down into the child's mouth. The nurse reported that the child ingested the contests of the cold pack after which the facility consulted with the poison control center. The poison control center recommended to have the child consume several glasses of water however according to the nurse the patient was on fluid restrictions due to an unrelated medical condition. The medical treatment team decided that since the child ingested such a small amount of the cold pack content the patient would stick to the current fluid restrictions and continue to be monitored during the current hospitalization for the unrelated medical issue. The sample was returned for evaluation and the customer reported issue was confirmed. The leaking content was seen from a very small pin hole that was observed on the cold pack. The root cause was found to be due to a sharp object puncturing the pouch. No additional information is available. Due to the reported incident and in an abundance of caution, this medwatch is being filed. If additional relevant information becomes available a supplemental medwatch will be filed.
Patient Sequence No: 1, Text Type: N, H10
[186543659]
It was reported that a cold pack leaked and a child ingested a small amount of the contents.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1417592-2020-00023 |
| MDR Report Key | 9857115 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-03-19 |
| Date of Report | 2020-03-19 |
| Date of Event | 2020-01-31 |
| Date Mfgr Received | 2020-02-25 |
| Date Added to Maude | 2020-03-19 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | KAREN TRUTSCH |
| Manufacturer Street | THREE LAKES DRIVE |
| Manufacturer City | NORTHFIELD, IL |
| Manufacturer Country | US |
| Manufacturer Phone | 6434960 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | PACK,COLD,INSTNT,DLX,SWEATLESS,5"X7.5" |
| Product Code | IMD |
| Date Received | 2020-03-19 |
| Returned To Mfg | 2020-03-16 |
| Catalog Number | MDS148010 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES INC. |
| Manufacturer Address | THREE LAKES DRIVE NORTHFIELD, IL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-03-19 |