MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-06-30 for PIGG-O-STAT NOT GIVEN manufactured by Modern Way Immobilizer.
[78814916]
Patient Sequence No: 1, Text Type: N, H10
[78814917]
Child's mother called to report that her child was in emergency department last night and was taken to radiology for a chest x-ray. The baby was placed in a pigg-o-stat immobilizer for the exam. After he was brought back to the ed room he had a small amount of swelling on his head in left occipital area. Mother reports that the baby had increased swelling of the area and had to take baby to another hospital where the baby underwent a ct of the head that showed soft tissue swelling.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6680461 |
| MDR Report Key | 6680461 |
| Date Received | 2017-06-30 |
| Date of Report | 2017-06-20 |
| Date of Event | 2017-05-29 |
| Report Date | 2017-06-14 |
| Date Reported to FDA | 2017-06-14 |
| Date Reported to Mfgr | 2017-06-14 |
| Date Added to Maude | 2017-06-30 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PIGG-O-STAT |
| Generic Name | INFANT IMMOBILIZER |
| Product Code | KXH |
| Date Received | 2017-06-30 |
| Model Number | NOT GIVEN |
| Lot Number | UNKNOWN |
| Device Availability | Y |
| Device Age | 3 YR |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | MODERN WAY IMMOBILIZER |
| Manufacturer Address | P.O. BOX 660 104 JOHNSON ST. CLIFTON TN 38425 US 38425 |
| Brand Name | PIGG-O-STAT |
| Generic Name | INFANT IMMOBILIZER |
| Product Code | PRN |
| Date Received | 2017-06-30 |
| Model Number | NOT GIVEN |
| Lot Number | UNKNOWN |
| Device Availability | Y |
| Device Age | 3 YR |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MODERN WAY IMMOBILIZER |
| Manufacturer Address | P.O. BOX 660 104 JOHNSON ST. CLIFTON TN 38425 US 38425 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-06-30 |