MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-12-21 for DYNJ0718669C manufactured by Medline Industries Inc..
[95620056]
It was reported that there was an arch during an unknown procedure and it caused a small fire. The fire was put out right away with no patient impact and no property damage. Numerous attempts have been made to attempt to contact the facility to obtain additional information related to the incident; however no additional details were available. There was no injury reported. There was no report of any adverse patient consequence and no effect on the patient's stability as a result of the incident. No additional information is available. A sample has not been returned for evaluation however, due to the reported incident and in an abundance of caution, this medwatch is being filed. If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[95620057]
It was reported that there was an arch during a case and it caused a small fire. The fire was put out right away with no patient impact and no property damage.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423395-2017-00030 |
| MDR Report Key | 7137663 |
| Date Received | 2017-12-21 |
| Date of Report | 2017-12-21 |
| Date of Event | 2017-11-29 |
| Date Mfgr Received | 2017-11-29 |
| Date Added to Maude | 2017-12-21 |
| 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 | KAREN TRUTSCH |
| Manufacturer Street | THREE LAKES DRIVE |
| Manufacturer City | NORHFIELD IL 60093 |
| Manufacturer Country | US |
| Manufacturer Postal | 60093 |
| Manufacturer Phone | 8476434960 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Generic Name | C-SECTION PACK |
| Product Code | OHM |
| Date Received | 2017-12-21 |
| Catalog Number | DYNJ0718669C |
| Lot Number | 17UB5522 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES INC. |
| Manufacturer Address | THREE LAKES DRIVE NORTHFIELD IL 60093 US 60093 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-12-21 |