MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06,07 report with the FDA on 2013-12-17 for MEROCEL STANDARD NASAL DRESSING 400402 manufactured by Medtronic Xomed, Inc.
[18572628]
It was reported that a surgeon performed ess, and after placing a merocel in the patient it was accidentally swallowed. This issue has not been considered to be a product malfunction [by the user] and the customer just wanted to know if these cases have been previously reported from the other hospitals. The part number was confirmed, lot number remains unidentified. It was confirmed that the patient was prescribed a laxative, but the result remains unknown.
Patient Sequence No: 1, Text Type: D, B5
[18769374]
(b)(4). The product is not expected to be returned for analysis. No testing methods performed. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1045254-2013-00605 |
| MDR Report Key | 3523608 |
| Report Source | 01,05,06,07 |
| Date Received | 2013-12-17 |
| Date of Report | 2013-11-24 |
| Date of Event | 2013-11-21 |
| Date Mfgr Received | 2013-11-24 |
| Date Added to Maude | 2014-03-27 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | AMY CORRALES |
| Manufacturer Street | 6743 SOUTHPOINT DRIVE NORTH |
| Manufacturer City | JACKSONVILLE FL 32216 |
| Manufacturer Country | US |
| Manufacturer Postal | 32216 |
| Manufacturer Phone | 9043328138 |
| Manufacturer G1 | MEDTRONIC XOMED, INC. |
| Manufacturer Street | 6743 SOUTHPOINT DRIVE NORTH |
| 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 STANDARD NASAL DRESSING |
| Generic Name | GAUZE/SPONGE,NONRESORBABLE FOR EXTERNAL USE |
| Product Code | GER |
| Date Received | 2013-12-17 |
| Model Number | 400402 |
| Catalog Number | 400402 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC XOMED, INC |
| Manufacturer Address | 6743 SOUTHPOINT DRIVE NORTH JACKSONVILLE FL 32216 US 32216 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-12-17 |