MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 1997-12-30 for PERFIX PLUG * ZPQNO-STK manufactured by Davol, Inc., Sub. C.r. Bard, Inc..
[20469291]
Pt infection.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 1213643-1997-00081 |
MDR Report Key | 141587 |
Report Source | 05 |
Date Received | 1997-12-30 |
Date of Report | 1997-12-30 |
Date of Event | 1997-11-28 |
Date Mfgr Received | 1997-12-03 |
Date Added to Maude | 1998-01-07 |
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 | 0 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | PERFIX PLUG |
Generic Name | HERNIA PLUG |
Product Code | EXN |
Date Received | 1997-12-30 |
Model Number | * |
Catalog Number | ZPQNO-STK |
Lot Number | 086620 |
ID Number | * |
Operator | HEALTH PROFESSIONAL |
Device Availability | N |
Device Eval'ed by Mfgr | R |
Implant Flag | N |
Date Removed | * |
Device Sequence No | 1 |
Device Event Key | 138140 |
Manufacturer | DAVOL, INC., SUB. C.R. BARD, INC. |
Manufacturer Address | 100 SOCKANOSSETT CROSSROAD CRANSTON RI 02920 US |
Baseline Brand Name | MARLEX MESH |
Baseline Generic Name | SURGICAL MESH |
Baseline Model No | NA |
Baseline Catalog No | ZPQNO-STK |
Baseline ID | NA |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1997-12-30 |