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 |