MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-10-05 for HMS WARM PACK N/A manufactured by Hospital Marketing Services, Inc..
[601]
Chemical warm pack placed on premature infant without a protective barrier. Infant sustained 2nd degree burn. Warm pack is not labeled: "heat packs should not be used on infants or persons with sensory or circulatory impairment". This statement is included on product information sheet obtained from company. Company states they have another warm pack intended for use on infantsdevice labeled for single use. Patient medical status prior to event: critical condition. There was not multiple patient involvement. Invalid data - on device service/maintenance. No data - regarding date last serviced. Service provided by: invalid data. Invalid data - service records availability. No imminent hazard to public health claimed. Device used as labeled/intended. Device was not evaluated after the event. Method of evaluation: no data. Results of evaluation: no data. Conclusion: no data. Certainty of device as cause of or contributor to event: yes. Corrective actions: device use continued with restrictions/limitations, user education provided. The device was destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1465 |
| MDR Report Key | 1465 |
| Date Received | 1992-10-05 |
| Date of Event | 1992-09-12 |
| Date Facility Aware | 1992-09-12 |
| Date Reported to Mfgr | 1992-09-24 |
| Date Added to Maude | 1992-10-14 |
| 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 | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HMS WARM PACK |
| Generic Name | N/A |
| Product Code | IMA |
| Date Received | 1992-10-05 |
| Model Number | N/A |
| Catalog Number | N/A |
| Lot Number | 1448G-D |
| ID Number | N/A |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | N |
| Device Age | 01-AUG-92 |
| Implant Flag | N |
| Device Sequence No | 1 |
| Device Event Key | 1403 |
| Manufacturer | HOSPITAL MARKETING SERVICES, INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1992-10-05 |