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..
[47387]
During a hot pack treatment, pt developed a burn on right elbow. Pt was admitted for rehabilitation for central cord syndrome. Event occurred during the inpatient stay.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 76033 |
| MDR Report Key | 76033 |
| Date Received | 1997-01-17 |
| Date of Report | 1997-01-17 |
| Date of Event | 1996-11-07 |
| 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 | OCCUPATIONAL 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 | 75783 |
| 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 |