MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-11-04 for BARRIER * 620105 manufactured by Molnlycke Healthcare, Us Llc.
[5061848]
A small piece of what looked like a fiber or fleck of paper fell into the wound bed during surgery. The surgeon stated that it was approximately 1-2 mm and came from the blue surgical hood he was wearing. The surgeon reported having other instances where pieces of foreign material form the hood were a little larger 2-3 mm. The wound was irrigated and the case aborted. The patient received antibiotics and will be rescheduled for surgery in 3 weeks. The flecks of paper coming off of the hoods may be related to the cardboard box they are shipped in. The hoods do not have any internal wrapping that protects them from the box. It may also be related to the materials used to process the hoods, we are not sure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 4239299 |
| MDR Report Key | 4239299 |
| Date Received | 2014-11-04 |
| Date of Report | 2014-11-04 |
| Date of Event | 2014-10-01 |
| Report Date | 2014-11-04 |
| Date Reported to FDA | 2014-11-04 |
| Date Reported to Mfgr | 2014-11-10 |
| Date Added to Maude | 2014-11-10 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BARRIER |
| Generic Name | SURGICAL HOOD |
| Product Code | FXY |
| Date Received | 2014-11-04 |
| Model Number | * |
| Catalog Number | 620105 |
| Lot Number | 13056504 |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | 1 DA |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MOLNLYCKE HEALTHCARE, US LLC |
| Manufacturer Address | 5550 PEACHTREE PARKWAY SUITE 500 NORCROSS GA 30092255 US 30092 2555 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2014-11-04 |