MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2014-01-10 for SM PLUS BTT/ROUND BALLOON DISSECTOR SMBTTRND manufactured by Covidien, Formerly Us Sur.
[4181606]
Procedure: tep. Packing part of trocar came off when the balloon was being removed. New device was used. Operating time was not extended. Additional information requested via email.
Patient Sequence No: 1, Text Type: D, B5
[11629510]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1219930-2014-00036 |
| MDR Report Key | 3645323 |
| Report Source | 01,05,06 |
| Date Received | 2014-01-10 |
| Date of Report | 2013-12-20 |
| Date of Event | 2013-12-06 |
| Date Mfgr Received | 2013-12-20 |
| Date Added to Maude | 2014-04-16 |
| 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 AVENUE |
| Manufacturer City | NORTH HAVEN CT 06473 |
| Manufacturer Country | US |
| Manufacturer Postal | 06473 |
| Manufacturer Phone | 2034925267 |
| Manufacturer G1 | COVIDIEN, FORMERLY US SURGICAL |
| Manufacturer Street | 60 MIDDLETOWN AVENUE |
| Manufacturer City | NORTH HAVEN CT 06473 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 06473 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SM PLUS BTT/ROUND BALLOON DISSECTOR |
| Generic Name | SPACEMAKER BALLOON |
| Product Code | GDI |
| Date Received | 2014-01-10 |
| Catalog Number | SMBTTRND |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN, FORMERLY US SUR |
| Manufacturer Address | 60 MIDDLETOWN AVENUE NORTH HAVEN CT 06473 US 06473 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-01-10 |