MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2007-08-20 for MEROCEL 2000, 8CM WITH AIRWAY AND DRAWSTRING 10/BOX, STERILE 470405 manufactured by Medtronic Ent.
[681309]
Info provided by medwatch was received from customer contact who reported: pt had functional rhinoplasty and submucous resection of the left inferior turbinate. A merocel airway splint was trimmed, saturated with bacitracin ointment. A silk pull-out suture was placed, and (the merocel) was put into the left nasal cavity. The pt was checked out (c/o) coughing and sore throat. Thirty six hours later, the pt (reported he) was unable to breathe. (pt) performed heimlich maneuver on self, coughing up the nasal airway splint. Dr has made a suggestion when only one nasal packing with splint is used in the future, he will tape the string to the face. Normally two (2) devices are used, and they are tied together.
Patient Sequence No: 1, Text Type: D, B5
[8124605]
Lot unk. User (surgeon) failed to follow the ifus/instructions that was provided, to tape the string to the face. The device is sold one per pack, so the instructions for use are setup for them to be used individually. Product returned by the pt.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1045254-2007-00006 |
| MDR Report Key | 902287 |
| Report Source | 05 |
| Date Received | 2007-08-20 |
| Date of Report | 2007-08-17 |
| Date of Event | 2007-07-25 |
| Date Mfgr Received | 2007-08-03 |
| Date Added to Maude | 2007-08-27 |
| 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 | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | BILL WIGGINS |
| Manufacturer Street | 6743 SOUTHPOINT DR N |
| Manufacturer City | JACKSONVILLE FL 32216 |
| Manufacturer Country | US |
| Manufacturer Postal | 32216 |
| Manufacturer Phone | 9043328196 |
| Manufacturer G1 | MEDTRONIC ENT |
| Manufacturer Street | 6743 SOUTHPOINT DR N |
| Manufacturer City | JACKSONVILLE FL 32216 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 32216 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MEROCEL 2000, 8CM WITH AIRWAY AND DRAWSTRING 10/BOX, STERILE |
| Generic Name | MEROCEL STERILE DISPOSABLE |
| Product Code | EMX |
| Date Received | 2007-08-20 |
| Model Number | 470405 |
| Catalog Number | 470405 |
| Lot Number | UNK |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 875129 |
| Manufacturer | MEDTRONIC ENT |
| Manufacturer Address | * JACKSONVILLE FL 32216 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2007-08-20 |