MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2003-05-21 for BARRIER EXTRA PROTECTION PLUS GOWN, LARGE 0540 manufactured by Molnlycke Health Care, Inc..
[305710]
Initial report from territory sales manager, concerning on account that had just converted from using an entire fluid impervious gown to a fluid zoned impervious gown. This report is filed for no. 1 above; company representative (sales manager) visited the hospital and was unable to gather additional info for this report. No bloodborne pathogen exposure was reported.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 2523357-2003-00001 |
MDR Report Key | 461785 |
Report Source | 07 |
Date Received | 2003-05-21 |
Date of Report | 2003-05-20 |
Date of Event | 2003-04-20 |
Date Mfgr Received | 2003-04-22 |
Date Added to Maude | 2003-05-28 |
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 |
Manufacturer Contact | LINDA HENDRICKS, MANAGER |
Manufacturer Street | 826 NEWTOWN-YARDLEY ROAD |
Manufacturer City | NEWTOWN PA 18940 |
Manufacturer Country | US |
Manufacturer Postal | 18940 |
Manufacturer Phone | 8008824582 |
Manufacturer G1 | * |
Manufacturer Street | * |
Manufacturer City | * |
Manufacturer Country | * |
Single Use | 3 |
Remedial Action | OT |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | BARRIER EXTRA PROTECTION PLUS GOWN, LARGE |
Generic Name | GOWN, SURGICAL |
Product Code | FYE |
Date Received | 2003-05-21 |
Model Number | NA |
Catalog Number | 0540 |
Lot Number | UNK |
ID Number | NA |
Operator | HEALTH PROFESSIONAL |
Device Availability | N |
Device Eval'ed by Mfgr | R |
Implant Flag | N |
Date Removed | A |
Device Sequence No | 1 |
Device Event Key | 450728 |
Manufacturer | MOLNLYCKE HEALTH CARE, INC. |
Manufacturer Address | 826 NEWTOWN-YARDLEY RD. NEWTOWN PA 18940 US |
Baseline Brand Name | BARRIER SURGICAL GOWN |
Baseline Generic Name | GOWN, SURGICAL |
Baseline Catalog No | 0540 |
Baseline ID | 9540 |
Baseline Device Family | SURGICAL GOWNS |
Baseline Shelf Life Contained | Y |
Baseline Shelf Life [Months] | 60 |
Baseline PMA Flag | N |
Baseline 510K PMN | Y |
Premarket Notification | K760903 |
Baseline Preamendment | N |
Baseline Transitional | N |
510k Exempt | N |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Other | 2003-05-21 |