MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-03-09 for SEABROOK UNIT/PAD N/A SMS 2000 manufactured by Seabrook Medical Systems.
[4993]
It was reported that a pt sustained blistering of her abdomen approx. Two days after this pad and unit was placed on her for therapy. The reporter had the unit and the pad tested and both pieces of equipment were found to function within specs for this product line. Device not labeled for single use. Patient medical status prior to event: fair condition. There was not multiple patient involvement. Device serviced in accordance with service schedule. Date last serviced: 01-jan-92. Service provided by: user facility biomedical/bioengineering department. Service records available. No imminent hazard to public health claimed. Device used as labeled/intended. Device was evaluated after the event. Method of evaluation: actual device involved in incident was evaluated, performance tests performed. Results of evaluation: none or unknown, none or unknown, none or unknown, patient's condition - predisposed event. Conclusion: device evaluated and alleged failure could not be duplicated, none or unknown. Certainty of device as cause of or contributor to event: unknown (cannot determine). Corrective actions: device temporarily removed from service. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 36869-1994-00001 |
| MDR Report Key | 8615 |
| Date Received | 1994-03-09 |
| Date of Report | 1994-02-21 |
| Date of Event | 1994-01-21 |
| Date Facility Aware | 1994-01-24 |
| Report Date | 1994-02-21 |
| Date Reported to FDA | 1994-02-21 |
| Date Reported to Mfgr | 1994-02-03 |
| Date Added to Maude | 1994-10-14 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | UNKNOWN |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SEABROOK UNIT/PAD |
| Generic Name | COOLING/HEATING UNIT |
| Product Code | IRQ |
| Date Received | 1994-03-09 |
| Model Number | N/A |
| Catalog Number | SMS 2000 |
| Lot Number | NA |
| ID Number | NA |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | Y |
| Device Age | 01-JAN-92 |
| Implant Flag | N |
| Device Sequence No | 1 |
| Device Event Key | 8281 |
| Manufacturer | SEABROOK MEDICAL SYSTEMS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1994-03-09 |