MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 1997-01-24 for EXETER CUP INTRODUCER 0930-3-000 manufactured by Howmedica Inc..
[43206]
The locking mechanism connecting handle and distal part is broken. There was no adverse consequence for the pt or delay in surgery or anesthesia time.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 8010096-1997-00003 |
MDR Report Key | 65397 |
Report Source | 01,07 |
Date Received | 1997-01-24 |
Date of Report | 1997-01-24 |
Report Date | 1997-01-23 |
Date Mfgr Received | 1996-12-20 |
Date Added to Maude | 1997-01-30 |
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 CUP INTRODUCER |
Generic Name | INSTRUMENT |
Product Code | KIL |
Date Received | 1997-01-24 |
Model Number | NA |
Catalog Number | 0930-3-000 |
Lot Number | NA |
ID Number | NA |
Operator | OTHER |
Device Availability | R |
Device Age | UNKNOWN |
Device Eval'ed by Mfgr | N |
Implant Flag | N |
Date Removed | A |
Device Sequence No | 1 |
Device Event Key | 65491 |
Manufacturer | HOWMEDICA INC. |
Manufacturer Address | 359 VETERANS BLVD RUTHERFORD NJ 07070 US |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Other | 1997-01-24 |