MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2014-11-20 for BARRIER SURGICAL GOOD - CAP TUCK BLUE 620105 manufactured by Molnlycke Healthcare.
[19091538]
(b)(4). The barrier surgical hood, 620105, was shedding in (b)(6) and falling from the top of the hood from the healthcare worker into the sterile surgical field.
Patient Sequence No: 1, Text Type: D, B5
[19126829]
Pt was anesthetized. Lint entered the surgical site but was removed successfully. Wound was closed up and surgery was postponed. He was placed on antibiotics. It is unk whether pt experienced any postoperative complications or whether he presented at follow up with any problems that could be associated with retained lining material.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004763499-2014-00020 |
| MDR Report Key | 4281473 |
| Report Source | 05,06 |
| Date Received | 2014-11-20 |
| Date of Report | 2014-11-17 |
| Date of Event | 2014-10-16 |
| Date Mfgr Received | 2014-10-23 |
| Date Added to Maude | 2014-11-28 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | JAMIE BRADSHAW |
| Manufacturer Street | 5550 PEACHTREE PARKWAY SUITE 500 |
| Manufacturer City | NORCROSS GA 30092 |
| Manufacturer Country | US |
| Manufacturer Postal | 30092 |
| Manufacturer Phone | 6782507912 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BARRIER SURGICAL GOOD - CAP TUCK BLUE |
| Product Code | FYF |
| Date Received | 2014-11-20 |
| Model Number | 620105 |
| Catalog Number | 620105 |
| Lot Number | 13056504 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MOLNLYCKE HEALTHCARE |
| Manufacturer Address | NORCROSS GA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-11-20 |