MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2015-05-18 for SM PLUS SBT/ROUND BALLOON DISSECTOR SMSBTRND manufactured by Covidien, Formerly Us Surgical A Divison.
[5816985]
Procedure: laparoscopic inguinal hernia repair. According to the reporter:the structural balloon had a hole in it and did not inflate. There was no patient injury or hazard. There was no unanticipated tissue loss. The incision was not extended by more than one inch. There was no unanticipated blood loss of 500cc or more. Surgery time was not delayed by more than 30 minutes. No device fragment fell into the patient.
Patient Sequence No: 1, Text Type: D, B5
[13360245]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1219930-2015-00408 |
| MDR Report Key | 4778117 |
| Report Source | 06 |
| Date Received | 2015-05-18 |
| Date of Report | 2015-04-20 |
| Date of Event | 2015-04-20 |
| Date Mfgr Received | 2015-04-20 |
| Date Added to Maude | 2015-06-17 |
| 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 | 0 |
| 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 US SURGICAL A DIVISON |
| Manufacturer Street | 60 MIDDLETOWN AVE |
| 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 SBT/ROUND BALLOON DISSECTOR |
| Generic Name | SPACE MAKER BALLOON |
| Product Code | GDI |
| Date Received | 2015-05-18 |
| Returned To Mfg | 2015-05-05 |
| Model Number | SMSBTRND |
| Catalog Number | SMSBTRND |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN, FORMERLY US SURGICAL A DIVISON |
| Manufacturer Address | 60 MIDDLETOWN AVE NORTH HAVEN CT 06473 US 06473 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-05-18 |