MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-04-12 for SPACEMAKER PLUS BTT * SMBTTOVL manufactured by Covidien.
[3348515]
During bilateral hernia procedure spacemaker balloon was inserted to create space inside peritoneum. Balloon failed to inflate, device was removed and new device used. What was the original intended procedure? Laparoscopic bilateral inguinal hernia repair. Device #1is this a laboratory device or laboratory test? No.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3086992 |
| MDR Report Key | 3086992 |
| Date Received | 2013-04-12 |
| Date of Report | 2013-04-01 |
| Date of Event | 2013-03-29 |
| Report Date | 2013-04-01 |
| Date Reported to FDA | 2013-04-12 |
| Date Reported to Mfgr | 2013-05-01 |
| Date Added to Maude | 2013-05-01 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SPACEMAKER PLUS BTT |
| Generic Name | DISSECTOR, SURGICAL, GENERAL & PLASTIC SURGERY, BALLOON |
| Product Code | GDI |
| Date Received | 2013-04-12 |
| Model Number | * |
| Catalog Number | SMBTTOVL |
| Lot Number | P3A0223X |
| ID Number | * |
| Device Availability | Y |
| Device Age | 1 DY |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Manufacturer Address | 15 HAMPSHIRE STREET MANSFIELD MA * US * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-04-12 |