MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-12 for SURGEONS HOOD TUCK BLUE 620105 manufactured by Molnlycke Healthcare.
[117145970]
Actual model # 620100-11. This report was submitted for similar model. Corrective and preventive actions have been implemented. Zero (0) similar reports have been received. Monitoring for same/similar reports will be conducted.
Patient Sequence No: 1, Text Type: N, H10
[117145971]
During surgery, the staff realized that the surgical hood was fraying and material residue fell into the surgical site. The hood was changed and the wound site was cleansed to remove foreign material and explored to confirm removal. Follow up information received on (b)(6) 2018 reported the patient did not experience any post-op complications or other problems associated with the reported issue and that the residue had been successfully removed. No additional information is available or expected.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004763499-2018-00002 |
| MDR Report Key | 7775812 |
| Date Received | 2018-08-12 |
| Date of Report | 2018-04-19 |
| Date of Event | 2018-04-10 |
| Date Mfgr Received | 2018-04-19 |
| Device Manufacturer Date | 2017-07-21 |
| Date Added to Maude | 2018-08-12 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS PAT STRAHL |
| Manufacturer Street | 5550 PEACHTREE PARKWAY SUITE 500 |
| Manufacturer City | NORCROSS GA 30092 |
| Manufacturer Country | US |
| Manufacturer Postal | 30092 |
| Manufacturer Phone | 4703750171 |
| Manufacturer G1 | MOLNLYCKE HEALTHCARE |
| Manufacturer Street | 5550 PEACHTREE PARKWAY SUITE 500 |
| Manufacturer City | NORCROSS GA 30092 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 30092 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | SURGEONS HOOD TUCK BLUE |
| Generic Name | BARRIER SURGICAL HOOD |
| Product Code | FYF |
| Date Received | 2018-08-12 |
| Model Number | 620105 |
| Lot Number | 17226504 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MOLNLYCKE HEALTHCARE |
| Manufacturer Address | 5550 PEACHTREE PARKWAY SUITE 500 NORCROSS GA 30092 US 30092 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-08-12 |