MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2012-08-24 for SM PLUS BTT/ OVAL BALLOON DISSECTOR SMBTTOVL manufactured by Covidien, Formerly Ussc.
[3051445]
Procedure type: lap hernia repair. According to the reporter: faulty balloon.
Patient Sequence No: 1, Text Type: D, B5
[10217561]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2647580-2012-00564 |
| MDR Report Key | 2719395 |
| Report Source | 06 |
| Date Received | 2012-08-24 |
| Date of Report | 2012-07-25 |
| Date of Event | 2012-07-02 |
| Date Mfgr Received | 2012-07-25 |
| Device Manufacturer Date | 2011-09-01 |
| Date Added to Maude | 2012-12-11 |
| 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 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 | SM PLUS BTT/ OVAL BALLOON DISSECTOR |
| Generic Name | SPACEMAKER BALLOON |
| Product Code | GDI |
| Date Received | 2012-08-24 |
| Catalog Number | SMBTTOVL |
| Lot Number | P1J0390 |
| Device Expiration Date | 2013-09-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2012-08-24 |