MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2008-10-21 for STEAM PACK STANDARD BOXED 1006 manufactured by Chattanooga Group.
[20937734]
About 5 years ago one of your hydrocollator steam packs, part number 1006, exploded on me. I was burned, but not seriously. I was very angry as i had followed directions carefully. You would have heard from me then, but a family member died and i was otherwise occupied. Today i ran across the instruction sheet for the steam packs and decided i should let you know that your product was defective and dangerous.
Patient Sequence No: 1, Text Type: D, B5
[21236038]
The customer did not return the device for eval. Since the device was not returned for eval, no root cause can be determined. Additional info will be provided via the form 3500a, if required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1022819-2008-00190 |
| MDR Report Key | 1205963 |
| Report Source | 04 |
| Date Received | 2008-10-21 |
| Date of Report | 2003-07-07 |
| Date of Event | 2003-07-07 |
| Date Mfgr Received | 2008-07-07 |
| Date Added to Maude | 2008-10-27 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MR. MICHAEL TREAS |
| Manufacturer Street | 4717 ADAMS RD. |
| Manufacturer City | HIXSON TN 37343 |
| Manufacturer Country | US |
| Manufacturer Postal | 37343 |
| Manufacturer Phone | 4238702281 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STEAM PACK STANDARD BOXED |
| Product Code | IMA |
| Date Received | 2008-10-21 |
| Model Number | 1006 |
| Catalog Number | 1006 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1255917 |
| Manufacturer | CHATTANOOGA GROUP |
| Manufacturer Address | HIXSON TN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2008-10-21 |