MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 1996-10-21 for EXETER INTRODUCER EXTRACTOR 0935-0-000 manufactured by Howmedica Inc.
[32451]
The device leaks. The liquid comes out of the thread. This event did not cause any adverse consequence to the pt or delay in surgical or anesthesia time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2219689-1996-90004 |
| MDR Report Key | 46241 |
| Report Source | 01,07 |
| Date Received | 1996-10-21 |
| Date of Report | 1996-10-18 |
| Report Date | 1996-10-11 |
| Date Mfgr Received | 1996-10-01 |
| Date Added to Maude | 1996-11-05 |
| 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 | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EXETER INTRODUCER EXTRACTOR |
| Generic Name | INSTRUMENT |
| Product Code | LZV |
| Date Received | 1996-10-21 |
| Model Number | NA |
| Catalog Number | 0935-0-000 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | UNKNOWN |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 47085 |
| Manufacturer | HOWMEDICA INC |
| Manufacturer Address | 359 VETERANS BLVD RUTHERFORD NJ 07070 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1996-10-21 |