MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-01-17 for HYDROCOLLATOR M-2 NA manufactured by Chattanooga Pharmacal Co..
[45820]
Pt sustained burn to left scapula after hot pack treatment.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 76035 |
MDR Report Key | 76035 |
Date Received | 1997-01-17 |
Date of Report | 1997-01-17 |
Date of Event | 1996-11-06 |
Date Facility Aware | 1996-11-06 |
Report Date | 1997-01-17 |
Date Reported to FDA | 1997-01-17 |
Date Reported to Mfgr | 1997-01-17 |
Date Added to Maude | 1997-03-17 |
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 |
Reporter Occupation | PHYSICAL THERAPIST |
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 | HYDROCOLLATOR |
Generic Name | HYDROCOLLATOR |
Product Code | IMA |
Date Received | 1997-01-17 |
Model Number | M-2 |
Catalog Number | NA |
Lot Number | NA |
ID Number | NA |
Operator | HEALTH PROFESSIONAL |
Device Availability | Y |
Device Age | 20 YR |
Implant Flag | N |
Date Removed | A |
Device Sequence No | 1 |
Device Event Key | 75785 |
Manufacturer | CHATTANOOGA PHARMACAL CO. |
Manufacturer Address | 4717 ADAMS RD PO BOX 489 HIXSON TN 373430489 US |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Required No Informationntervention | 1997-01-17 |