MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 1997-03-28 for 3M BRAND KENNEDY LAD BRAND manufactured by 3m Irvine Plant.
[50889]
"pt had an infection 3-6 weeks post-surgery only at the distal end where he makes a loop (belt buckle). He is using the staples on both the lad and those who don't have the lad. The proximal end does not seem to be affected. "
Patient Sequence No: 1, Text Type: D, B5
Report Number | 2110898-1997-00009 |
MDR Report Key | 80005 |
Report Source | 05 |
Date Received | 1997-03-28 |
Date Mfgr Received | 1997-02-04 |
Date Added to Maude | 1997-04-02 |
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 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | 3M BRAND KENNEDY LAD BRAND |
Generic Name | LIGAMENT AUGMENTATION DEVICE |
Product Code | LML |
Date Received | 1997-03-28 |
Model Number | NA |
Catalog Number | NA |
Lot Number | UNK |
ID Number | * |
Operator | HEALTH PROFESSIONAL |
Device Availability | * |
Device Age | * |
Device Eval'ed by Mfgr | R |
Implant Flag | Y |
Date Removed | * |
Device Sequence No | 1 |
Device Event Key | 79495 |
Manufacturer | 3M IRVINE PLANT |
Manufacturer Address | 17131 PULLMAN STREET IRVINE CA 927139695 US |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1997-03-28 |