MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2012-03-28 for SM PLUS BTT/OVAL BALLOON DISSECTOR SMBTTOVL manufactured by Covidien, Formerly Ussc.
[2573196]
Procedure type: inguinal hernia repair. Balloon would not inflate. Defective seal. Called down another dissector. Longer case time. There was no bleeding reported in excess of 250cc. There was no tissue damage or unanticipated tissue. Loss. Operation time not extended over 30 minutes.
Patient Sequence No: 1, Text Type: D, B5
[9724160]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2647580-2012-00227 |
| MDR Report Key | 2512769 |
| Report Source | 06 |
| Date Received | 2012-03-28 |
| Date of Report | 2012-03-23 |
| Date of Event | 2012-01-27 |
| Date Mfgr Received | 2012-03-23 |
| Device Manufacturer Date | 2011-12-01 |
| 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 | MELISSA ZAFFIN |
| Manufacturer Street | 60 MIDDLETOWN AVENUE |
| Manufacturer City | NORTH HAVEN CT 06473 |
| Manufacturer Country | US |
| Manufacturer Postal | 06473 |
| Manufacturer Phone | 2034927141 |
| 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 | SM PLUS BTT/OVAL BALLOON DISSECTOR |
| Generic Name | SPACEMAKER BALLOON |
| Product Code | GDI |
| Date Received | 2012-03-28 |
| Catalog Number | SMBTTOVL |
| Lot Number | P1M0006 |
| Device Expiration Date | 2013-12-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2012-03-28 |