MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-07-18 for THERMACHOICE III manufactured by Ethicon.
[15538685]
The therma choice balloon for the procedure did not obtain negative pressure within the pt. At this time another therma choice balloon was opened and worked properly. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5021375 |
| MDR Report Key | 2170623 |
| Date Received | 2011-07-18 |
| Date of Report | 2011-07-01 |
| Date of Event | 2011-06-23 |
| Date Added to Maude | 2011-07-25 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | THERMACHOICE III |
| Generic Name | NONE |
| Product Code | MKN |
| Date Received | 2011-07-18 |
| Lot Number | CKMG14 |
| ID Number | TC003 |
| Device Expiration Date | 2011-09-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ETHICON |
| Manufacturer Address | SOMERVILLE NJ 08876 US 08876 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-07-18 |