MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-02-25 for UNKNOWN TRI STAPLE PRODUCT UNK-TRISTAP manufactured by United States Surgical.
[1932936]
Procedure: thoracic. According to the reporter: the pt experienced bilateral soft tissue emphysema in chest wall and neck. The surgeon indicated that the device was possibly related to the event. The event required initial or prolonged hosp stay.
Patient Sequence No: 1, Text Type: D, B5
[9041153]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1219930-2011-00150 |
| MDR Report Key | 2010697 |
| Report Source | 05,06 |
| Date Received | 2011-02-25 |
| Date of Report | 2011-02-24 |
| Date of Event | 2011-01-11 |
| Date Mfgr Received | 2011-02-24 |
| Date Added to Maude | 2011-03-11 |
| 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 | TERRY CALLAHAN |
| Manufacturer Street | 195 MCDERMOTT RD |
| Manufacturer City | NORTH HAVEN CT 06473 |
| Manufacturer Country | US |
| Manufacturer Postal | 06473 |
| Manufacturer Phone | 2034926273 |
| Manufacturer Street | 195 MCDERMOTT RD |
| 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 | UNKNOWN TRI STAPLE PRODUCT |
| Generic Name | DISPOSABLE STAPLER |
| Product Code | FHM |
| Date Received | 2011-02-25 |
| Catalog Number | UNK-TRISTAP |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNITED STATES SURGICAL |
| Manufacturer Address | 195 MCDERMOTT RD NORTH HAVEN CT 06473 US 06473 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2011-02-25 |