MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2011-03-22 for AIRFORM UNIVERSAL INFLATABLE ANKLE STIRRUP 80250 manufactured by Ossur.
[18616571]
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.
Patient Sequence No: 1, Text Type: D, B5
[18699269]
The product is mfg to eliminate any material known to cause allergic reactions.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3026585-2011-00001 |
| MDR Report Key | 2032331 |
| Report Source | 05 |
| Date Received | 2011-03-22 |
| Date of Report | 2011-03-18 |
| Date of Event | 2011-02-05 |
| Date Mfgr Received | 2011-02-07 |
| Date Added to Maude | 2011-03-31 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | KAREN MONTES |
| Manufacturer Street | 19762 PAULING |
| Manufacturer City | FOOTHILL RANCH CA 92610 |
| Manufacturer Country | US |
| Manufacturer Postal | 92610 |
| Manufacturer Phone | 9492683155 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AIRFORM UNIVERSAL INFLATABLE ANKLE STIRRUP |
| Product Code | ITW |
| Date Received | 2011-03-22 |
| Catalog Number | 80250 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OSSUR |
| Manufacturer Address | FOOTHILL RANCH CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2011-03-22 |