MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-05-01 for STEP VERRES NEEDLE AND TROCAR S100000 manufactured by Innerdyne Medical.
[15006645]
Penetrated bowel wall of pt when using needle and trocar. (also see 1005780. )
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1005779 |
| MDR Report Key | 21603 |
| Date Received | 1995-05-01 |
| Date of Report | 1995-03-31 |
| Date of Event | 1995-03-29 |
| Date Added to Maude | 1995-05-03 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STEP VERRES NEEDLE AND TROCAR |
| Generic Name | VERRES NEEDLE & TROCAR |
| Product Code | FHP |
| Date Received | 1995-05-01 |
| Returned To Mfg | 1995-03-31 |
| Model Number | S100000 |
| Lot Number | 9502002 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 21645 |
| Manufacturer | INNERDYNE MEDICAL |
| Manufacturer Address | SUNNYVALE CA 94089 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 1995-05-01 |