MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2001-08-31 for BARRIER EXTRA PROTECTION PLUS SURGICAL GOWN 0540 manufactured by Molnlycke Health Care, Inc..
[245947]
Report received that while performing a lengthy and bloody abdominal case, strikethrough occurred around the sleeve from about the area just above the cuff of the glove to just below the elbow. The surgeon uses eudermic gloves that do not have a beaded cuff, however, the surgeon does not attribute the strikethrough because of the gloves. No known blood borne pathogens involved.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2523357-2001-00001 |
| MDR Report Key | 350021 |
| Date Received | 2001-08-31 |
| Date of Report | 2001-08-28 |
| Date of Event | 2001-08-02 |
| Date Mfgr Received | 2001-08-02 |
| Date Added to Maude | 2001-09-06 |
| 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 | KIM HARDING, DIR |
| Manufacturer Street | 2500 E. ARBROOK BLVD., STE. 3300 |
| Manufacturer City | ARLINGTON TX 76014 |
| Manufacturer Country | US |
| Manufacturer Postal | 76014 |
| Manufacturer Phone | 8172825278 |
| 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 EXTRA PROTECTION PLUS SURGICAL GOWN |
| Generic Name | GOWN, SURGICAL |
| Product Code | FYE |
| Date Received | 2001-08-31 |
| Model Number | NA |
| Catalog Number | 0540 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 339329 |
| Manufacturer | MOLNLYCKE HEALTH CARE, INC. |
| Manufacturer Address | 110 BALDWIN TOWER EDDYSTONE PA 19022 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 | 2001-08-31 |