MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06 report with the FDA on 2015-03-04 for GSI* SPACEMAKER BALLOON DISSECTOR 240CC VBD240T manufactured by Covidien, Formerly Ussc Puerto Rico Inc.
[19350015]
Procedure - subfascial endoscopic perforator surgery. According to the reporter, the balloon did not unfold: the invaginated distal part was still invaginated after instillation of 300ml fluid. It was also reported that the trocar sealed improperly at the wound. There was no harm to the patient.
Patient Sequence No: 1, Text Type: D, B5
[19519690]
(b)(4)
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2647580-2015-00152 |
| MDR Report Key | 4571027 |
| Report Source | 01,06 |
| Date Received | 2015-03-04 |
| Date of Report | 2015-02-09 |
| Date of Event | 2015-02-06 |
| Date Mfgr Received | 2015-02-09 |
| Device Manufacturer Date | 2013-03-07 |
| Date Added to Maude | 2015-04-03 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | SHARON MURPHY |
| Manufacturer Street | 60 MIDDLETOWN AVE |
| Manufacturer City | NORTH HAVEN CT 06473 |
| Manufacturer Country | US |
| Manufacturer Postal | 06473 |
| Manufacturer Phone | 2034925267 |
| Manufacturer G1 | COVIDIEN, FORMERLY USSC PUERTO RICO INC |
| Manufacturer Street | BUILDING 911-67 SABANETAS INDUSTRIAL PARK |
| Manufacturer City | PONCE PR 00731 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 00731 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GSI* SPACEMAKER BALLOON DISSECTOR 240CC |
| Generic Name | LAPAROSCOPE, GENERAL & PLASTIC SURGERY |
| Product Code | GDI |
| Date Received | 2015-03-04 |
| Model Number | VBD240T |
| Catalog Number | VBD240T |
| Lot Number | P3C0086X |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN, FORMERLY USSC PUERTO RICO INC |
| Manufacturer Address | BUILDING 911-67 SABANETAS INDUSTRIAL PARK PONCE PR 00731 US 00731 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-03-04 |