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 2012-04-02 for SPACEMAKER PREPERITONEAL DIST BALLOON OMSPDBS2 manufactured by Covidien, Formerly Ussc.
[2582612]
Procedure type: nephrectomy. According to the reporter: the balloon did not inflate. Used another to complete procedure. No bleeding. Nothing fell into cavity. No pt harm. Operating room time not extended more than 30 minutes.
Patient Sequence No: 1, Text Type: D, B5
[9951536]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2647580-2012-00246 |
| MDR Report Key | 2524576 |
| Report Source | 01,05,06 |
| Date Received | 2012-04-02 |
| Date of Report | 2012-03-05 |
| Date of Event | 2012-02-22 |
| Date Mfgr Received | 2012-03-05 |
| Date Added to Maude | 2012-09-06 |
| 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 | MELLISA ZAFFIN |
| Manufacturer Street | 60 MIDDLETOWN AVE. |
| Manufacturer City | NORTH HAVEN CT 06473 |
| Manufacturer Country | US |
| Manufacturer Postal | 06473 |
| Manufacturer Phone | 2034927141 |
| Manufacturer G1 | COVIDIEN, FORMERLY USSC PUERTO RICO |
| 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 | SPACEMAKER PREPERITONEAL DIST BALLOON |
| Generic Name | SPACEMAKER BALLOON |
| Product Code | GDI |
| Date Received | 2012-04-02 |
| Returned To Mfg | 2012-03-23 |
| Catalog Number | OMSPDBS2 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN, FORMERLY USSC |
| Manufacturer Address | BUILDING 911-67 PONCE PR 00731 US 00731 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-04-02 |