MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-07-01 for HYDROCOLLATOR M-2 UNK manufactured by Chattanooga Group.
[49043]
On 3/11/96, the pt had moist heat therapy to the right pectoralis muscle/deltoid region x 15min. , along with prom. The next day, the moist packs to the right shoulder were on hold due to an area on the right upper deltoid about the size of 3x3 1/2 with a blister inside 1x1 1/2. The pt was seen by a physician and apparently topical ointment was ordered for the area.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 84624 |
| MDR Report Key | 84624 |
| Date Received | 1996-07-01 |
| Date of Report | 1996-03-19 |
| Date of Event | 1996-03-11 |
| Date Facility Aware | 1996-03-11 |
| Report Date | 1996-03-19 |
| Date Reported to Mfgr | 1996-03-19 |
| Date Added to Maude | 1997-04-21 |
| 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 | RISK MANAGER |
| 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 | HOT PACK HEATER |
| Product Code | IMA |
| Date Received | 1996-07-01 |
| Model Number | M-2 |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | UNKNOWN |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 83876 |
| Manufacturer | CHATTANOOGA GROUP |
| Manufacturer Address | 4717 ADAMS RD HIXSON TN 37343 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1996-07-01 |