MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2002-04-23 for BARRIER ULTRA PROTECTION SURGICAL GOWN, EXTRA, EXTRA LARGE 0583 manufactured by Molnlycke Health Care, Inc..
[17173595]
Surgeon was performing a "somewhat bloody" procedure and experienced strikethrough, while wearing the barrier ultra protection surgical gown, product code 0583. Blood soaked through to the surgeon's scrubs, including arms and chest. No known exposure to bloodborne pathogens.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2523357-2002-00001 |
| MDR Report Key | 389443 |
| Report Source | 05,07 |
| Date Received | 2002-04-23 |
| Date of Report | 2002-04-23 |
| Date of Event | 2002-04-02 |
| Date Mfgr Received | 2002-04-02 |
| Date Added to Maude | 2002-04-24 |
| 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 |
| Manufacturer Contact | KIM HARDING DIRECTOR |
| Manufacturer Street | 826 NEWTOWN-YARDLEY RD. |
| 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 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BARRIER ULTRA PROTECTION SURGICAL GOWN, EXTRA, EXTRA LARGE |
| Generic Name | GOWN, SURGICAL |
| Product Code | FYE |
| Date Received | 2002-04-23 |
| Model Number | NA |
| Catalog Number | 0583 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 378491 |
| 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 | 0583 |
| Baseline ID | 9783 |
| 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 | 2002-04-23 |