MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-10-15 for MEROCEL? 2000 LAMINATED KENNEDY SINUSTENT DRESSING 470530 manufactured by Xomed Mfg Mystic.
[123684203]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[123684204]
A health care professional (hcp) reported that the patient came back to the emergency room of the facility with ecboli from the packing and splint implants.
Patient Sequence No: 1, Text Type: D, B5
[128447107]
(b)(4) are no longer applicable. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[128447108]
A health care professional (hcp) reported via a manufacturer representative that the patient came back with sepsis from e. Coli 5 days after the surgery. Cultures are positive for the bacteria. The hcp noted that there were no interventions performed to prevent impact or injury in association with the splint and packing during the patient's return visit to the emergency room.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1219071-2018-00002 |
| MDR Report Key | 7964806 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-10-15 |
| Date of Report | 2018-11-27 |
| Date of Event | 2018-09-12 |
| Date Mfgr Received | 2018-11-01 |
| Device Manufacturer Date | 2017-09-01 |
| Date Added to Maude | 2018-10-15 |
| 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 | URIZA SHUMS |
| Manufacturer Street | 6743 SOUTHPOINT DRIVE NORTH |
| Manufacturer City | JACKSONVILLE FL 32216 |
| Manufacturer Country | US |
| Manufacturer Postal | 32216 |
| Manufacturer Phone | 9043328405 |
| Manufacturer G1 | XOMED MFG MYSTIC |
| Manufacturer Street | 950 FLANDERS RD |
| Manufacturer City | MYSTIC CT 06355 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 06355 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MEROCEL? 2000 LAMINATED KENNEDY SINUSTENT DRESSING |
| Generic Name | SPLINT, INTRANASAL SEPTAL |
| Product Code | LYA |
| Date Received | 2018-10-15 |
| Model Number | 470530 |
| Catalog Number | 470530 |
| Lot Number | 00020329 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | XOMED MFG MYSTIC |
| Manufacturer Address | 950 FLANDERS RD MYSTIC CT 06355 US 06355 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-10-15 |