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 SURGICAL GOWN, EXTRA LARGE 0541 manufactured by Molnlycke Health Care, Inc..
[305574]
Initial report from territory sales manager, concerning an account that had just converted from using an entire fluid impervious gown to a fluid zoned inpervious gown. The customer alleged strikethrough of fluid in the abdomen. A total of five incidents were reported from this hospital for the following: 1) bowel resection, 2) incision and drainage (i&d) - two surgeons, 3) total hip replacement and 4) severe gunshot wound. This report is filed for no. 3 above; subsequent follow-up by territory sales manager with the doctor involved in the reported incident found that the strikethrough may have occurred in the thigh/knee area, which is outside of the reinforcement panel of the gown. No bloodborrne pathogen exposure was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2523357-2003-00004 |
| MDR Report Key | 461765 |
| 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 SURGICAL GOWN, EXTRA LARGE |
| Generic Name | GOWN, SURGICAL |
| Product Code | FYE |
| Date Received | 2003-05-21 |
| Model Number | NA |
| Catalog Number | 0541 |
| 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 | 450708 |
| 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 | 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 | 2003-05-21 |