FDA Adverse Event
Injury
Summary report: N
AIRFORM UNIVERSAL INFLATABLE ANKLE STIRRUP
MDR report key: 2032331
·
Received March 22, 2011
Report
- Report Number
- 3026585-2011-00001
- Event Type
- Injury
- Date Received
- March 22, 2011
- Date of Event
- February 5, 2011
- Report Date
- March 18, 2011
- Manufacturer
- OSSUR
- Product Code
- ITW
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WV, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE PRODUCT IS MFG TO ELIMINATE ANY MATERIAL KNOWN TO CAUSE ALLERGIC REACTIONS.
Description of Event or Problem · 1
PT HAD A PREEXISTING SMALL OPEN ULCER (ABOUT THE SIZE OF A QUARTER) THAT TURNED INTO A 4 CM ULCER AFTER WEARING A PRESCRIBED AIRFORM ANKLE STIRRUP FOR ONE DAY AND CLAIMS IT AGGRAVATED THE WOUND. THE ULCER DEVELOPED INTO CELLULITIS. PT SPENT FOUR DAYS IN THE HOSPITAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AIRFORM UNIVERSAL INFLATABLE ANKLE STIRRUP | ITW | OSSUR |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Hospitalization |