MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-09-24 for TARRY MANUFACTURING T901 manufactured by Tarry Manufacturing.
[1235251]
During use of positioning aid in the nicu, infant was noted when turning head that hood on bunting obstructed airway. High risk to infant when used in the hospital setting and even greater risk when infant is in the home, and is not being monitored. Will also fax report with copy of photo demonstrating airway obstruction.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5012864 |
| MDR Report Key | 1488116 |
| Date Received | 2009-09-24 |
| Date of Report | 2009-09-24 |
| Date of Event | 2009-09-16 |
| Date Added to Maude | 2009-10-05 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TARRY MANUFACTURING |
| Generic Name | TARRY MANUFACTURING DEVELOPMENTAL POSITIONING AID |
| Product Code | FRP |
| Date Received | 2009-09-24 |
| Model Number | T901 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TARRY MANUFACTURING |
| Manufacturer Address | 22 SHELTER ROCK LANE DANBURY CT 06010 US 06010 |
| Brand Name | TARRY MFG |
| Generic Name | TARRY MANUFACTURING DEVELOPMENTAL POSITIONING AID |
| Product Code | FRP |
| Date Received | 2009-09-24 |
| Model Number | T902 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | TARRY MANUFACTURING |
| Manufacturer Address | 22 SHELTER ROCK LANE DANBURY CT 06010 US 06010 |
| Brand Name | TARRY MANUFACTURING |
| Generic Name | TARRY MANUFACTURING DEVELOPMENTAL POSITIONING AID |
| Product Code | FRP |
| Date Received | 2009-09-24 |
| Model Number | T903 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 3 |
| Device Event Key | 0 |
| Manufacturer | TARRY MANUFACTURING |
| Manufacturer Address | 22 SHELTER ROCK LANE DANBURY CT 06010 US 06010 |
| Brand Name | TARRY MANUFACTURING |
| Generic Name | TARRY MANUFACTURING DEVELOPMENTAL POSITIONING AID |
| Product Code | FRP |
| Date Received | 2009-09-24 |
| Model Number | T904 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 4 |
| Device Event Key | 0 |
| Manufacturer | TARRY MANUFACTURING |
| Manufacturer Address | 22 SHELTER ROCK LANE DANBURY CT 06010 US 06010 |
| Brand Name | TARRY MANUFACTURING |
| Generic Name | TARRY MANUFACTURING DEVELOPMENTAL POSITIONING AID |
| Product Code | FRP |
| Date Received | 2009-09-24 |
| Model Number | T905 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 5 |
| Device Event Key | 0 |
| Manufacturer | TARRY MANUFACTURING |
| Manufacturer Address | 22 SHELTER ROCK LANE DANBURY CT 06010 US 06010 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2009-09-24 |