MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2007-01-30 for TCI- TUMESCENT CATHETER INVERSION SYSTEM 7210023 * manufactured by Smith & Nephew Inc., Endoscopy Division.
[16372485]
The perforated tubing pulled out of the green attachment causing 6" of vein not to be stripped. Sales rep. Stated that a hematoma was present, but the doctor was not concerned about it. It was indicated that the hematoma should clear up and there was no need for follow-up. There was no injury reported and the pt will not be having surgery to complete the case.
Patient Sequence No: 1, Text Type: D, B5
[16653679]
Device is not being returned for evaluation; therefore, no determination could be made for the reported incident.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1216828-2007-00002 |
| MDR Report Key | 818921 |
| Report Source | 05,07 |
| Date Received | 2007-01-30 |
| Date of Report | 2007-01-29 |
| Date of Event | 2007-01-03 |
| Date Facility Aware | 2007-01-03 |
| Report Date | 2007-01-29 |
| Date Mfgr Received | 2007-01-03 |
| Device Manufacturer Date | 2006-06-01 |
| Date Added to Maude | 2007-02-22 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | DONNA LANTEIGNE |
| Manufacturer Street | 150 MINUTEMAN ROAD |
| Manufacturer City | ANDOVER MA 01810 |
| Manufacturer Country | US |
| Manufacturer Postal | 01810 |
| Manufacturer Phone | 9787491576 |
| Manufacturer G1 | SMITH & NEPHEW, INC. |
| Manufacturer Street | 160 DASCOMB ROAD |
| Manufacturer City | ANDOVER MA 01810 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 01810 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TCI- TUMESCENT CATHETER INVERSION SYSTEM |
| Generic Name | * |
| Product Code | GAJ |
| Date Received | 2007-01-30 |
| Model Number | 7210023 |
| Catalog Number | * |
| Lot Number | 60847153 |
| ID Number | * |
| Device Expiration Date | 2009-04-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 7 MO |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 806405 |
| Manufacturer | SMITH & NEPHEW INC., ENDOSCOPY DIVISION |
| Manufacturer Address | * ANDOVER MA * US |
| Baseline Brand Name | TCI TUMESCENT CATHETER INVERSION SYSTEM |
| Baseline Generic Name | * |
| Baseline Model No | 7210023 |
| Baseline Catalog No | * |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-01-30 |