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 |