MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-16 for OXYMASK O2 KID OK-1125-8 manufactured by Southmedic Inc..
[145360171]
This incident was forwarded by southmedic's us distribution center with no contact information of the reporter provided; therefore, southmedic is unable to follow-up with the reporter for more information. Thus, no samples can be requested for investigation. The lot number provided in the medwatch report (mw5086084) does not match with the lot number format that southmedic uses on the device labeling. As a result, an investigation cannot be conducted with respect to the batch record of the device. [medwatch mw5086084. Pdf].
Patient Sequence No: 1, Text Type: N, H10
[145360172]
Pediatric oxymask was noted to be very loud with oxygen administration and the patient required increased oxygen. Upon examination of the oxymask, a kink in the tubing was noted at the base of the mask that twisted and blocked the oxygen administration to the patient. A different mask was placed on the patient and the problem resolved.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8022032-2019-00002 |
| MDR Report Key | 8617627 |
| Date Received | 2019-05-16 |
| Date of Report | 2019-05-16 |
| Date of Event | 2019-04-21 |
| Date Mfgr Received | 2019-05-08 |
| Date Added to Maude | 2019-05-16 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. TISH WHITEHEAD |
| Manufacturer Street | 50 ALLIANCE BLVD. |
| Manufacturer City | BARRIE, ONTARIO L4M 5K3 |
| Manufacturer Country | CA |
| Manufacturer Postal | L4M 5K3 |
| Manufacturer G1 | SOUTHMEDIC INC. |
| Manufacturer Street | 50 ALLIANCE BLVD. |
| Manufacturer City | BARRIE, ONTARIO L4M 5K3 |
| Manufacturer Country | CA |
| Manufacturer Postal Code | L4M 5K3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | OXYMASK O2 KID |
| Generic Name | OXYGEN MASK |
| Product Code | BYG |
| Date Received | 2019-05-16 |
| Model Number | OK-1125-8 |
| Lot Number | LO1936F |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SOUTHMEDIC INC. |
| Manufacturer Address | 50 ALLIANCE BLVD BARRIE, L4M 5K3 CA L4M 5K3 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-16 |