MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 1997-01-16 for PVP PREP SOLUTION UNK manufactured by Site-1623223- Surgical Group.
[20528083]
Plaintiff alleges severe and extensive chemical burns to his hip and groin area which did not exist before hip replacement surgery. Plaintiff alleges loss of consortium.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1623223-1997-00009 |
| MDR Report Key | 62381 |
| Report Source | 04 |
| Date Received | 1997-01-16 |
| Date of Report | 1997-01-16 |
| Date of Event | 1995-06-02 |
| Date Reported to Mfgr | 1996-12-31 |
| Date Mfgr Received | 1996-12-31 |
| Date Added to Maude | 1997-01-17 |
| 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 |
| Reporter Occupation | ATTORNEY |
| 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 | PVP PREP SOLUTION |
| Generic Name | PREP SOLUTION |
| Product Code | LOP |
| Date Received | 1997-01-16 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | * |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 62696 |
| Manufacturer | SITE-1623223- SURGICAL GROUP |
| Manufacturer Address | ONE BUTTERFIELD TRAIL ELPASO TX 79906 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1997-01-16 |