MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2018-04-12 for MEROCEL? 3000 - HEMOX DRESSING 450402 manufactured by Xomed Mfg Mystic.
[105286710]
The device has not been returned for evaluation. A product analysis has not been performed. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[105286711]
The customer reported that a nasal dressing was used for a laparoscopic formation of loop ileostomy, which had to be converted into an open procedure as they were unable to locate the nasal dressing. A nasal dressing was being used for hemostasis and could not be found using a laparoscope. An x-ray was used to try and locate the dressing, but it could not be detected via x-ray. The laparoscopic procedure was converted to an open procedure, which extended use of an anesthetic.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1219071-2018-00001 |
| MDR Report Key | 7425275 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-04-12 |
| Date of Report | 2018-04-12 |
| Date of Event | 2018-03-09 |
| Date Mfgr Received | 2018-03-15 |
| Device Manufacturer Date | 2017-08-01 |
| Date Added to Maude | 2018-04-12 |
| 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 | BIOMEDICAL ENGINEER |
| 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? 3000 - HEMOX DRESSING |
| Generic Name | SPLINT, INTRANASAL SEPTAL |
| Product Code | LYA |
| Date Received | 2018-04-12 |
| Model Number | 450402 |
| Catalog Number | 450402 |
| Lot Number | 00020327 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2018-04-12 |