MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2005-01-14 for BARRIER EXTRA PROTECTION PLUS SURGICAL GOWN, XL 0541 manufactured by Molnlycke Health Care, Ab.
[347499]
Strikethrough in the abdomen while performing an exploratory lap procedure using copious amounts of fluid. No known bloodborne pathogens; no adverse impact reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2523357-2005-00001 |
| MDR Report Key | 569276 |
| Report Source | 05,06 |
| Date Received | 2005-01-14 |
| Date of Report | 2005-01-13 |
| Date of Event | 2004-12-03 |
| Date Mfgr Received | 2004-12-08 |
| Device Manufacturer Date | 2002-03-01 |
| Date Added to Maude | 2005-02-02 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | JOHN CLAY |
| Manufacturer Street | 826 NEWTON-YARDLEY RD |
| Manufacturer City | NEWTON PA 18940 |
| Manufacturer Country | US |
| Manufacturer Postal | 18940 |
| Manufacturer Phone | 8008824582 |
| Manufacturer G1 | MOLNLYCKE HEALTH CARE LTD-THAILAND |
| Manufacturer Street | BANG PAKONG IND. EST. BANGNA TRAD RD KM57,TAMBOL DONHUAROH |
| Manufacturer City | AMPHUR MUANG, CHONBURI 20000 |
| Manufacturer Country | * |
| Manufacturer Postal Code | 20000 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BARRIER EXTRA PROTECTION PLUS SURGICAL GOWN, XL |
| Generic Name | GOWN, SURGICAL |
| Product Code | FYE |
| Date Received | 2005-01-14 |
| Model Number | NA |
| Catalog Number | 0541 |
| Lot Number | P0540302F10 |
| ID Number | NA |
| Device Expiration Date | 2007-03-31 |
| 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 | 559123 |
| Manufacturer | MOLNLYCKE HEALTH CARE, AB |
| Manufacturer Address | BOX 13080 GOT BORG SW SE-402 |
| Baseline Brand Name | BARRIER SURGICAL GOWN |
| Baseline Generic Name | GOWN, SURGICAL |
| Baseline Catalog No | 0541 |
| Baseline ID | 9541 |
| 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 | 2005-01-14 |