FDA Adverse Event
Injury
Summary report: N
3M SCOTCHCAST WET AND DRY CAST PADDING
MDR report key: 2896036
·
Received December 27, 2012
Report
- Report Number
- 2110898-2012-00071
- Event Type
- Injury
- Date Received
- December 27, 2012
- Date of Event
- November 14, 2012
- Report Date
- November 16, 2012
- Manufacturer
- 3M HEALTH CARE
- Product Code
- ITG
- PMA / PMN Number
- EXEMPT
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
NO LOT NUMBER WAS PROVIDED WITH PRODUCT. WITHOUT LOT NUMBER IT IS NOT POSSIBLE TO DETERMINE THE PRODUCT EXPIRATION DATE OR MANUFACTURE DATE. PRODUCT WAS AVAILABLE FOR EVALUATION APPLICABLE TO THE REPORTABLE EVENT BUT IT HAD NOT BEEN RETURNED TO THE MANUFACTURER. THE PRODUCT WAS NOT RETURNED TO 3M FOR EVALUATION.
Description of Event or Problem · 1
CUSTOMER REPORTED A (B)(6) FEMALE PATIENT PRESENTED WITH BLISTERS ON HER FOOT ABOUT 3 INCHES BELOW THE KNEE WITH NO REACTION WHERE THE STOCKINET WAS AT THE END OF THE SHORT LEG CAST, AND WAS TREATED WITH ANTIHISTAMINE, PRESCRIPTION STEROID CREAM AND ANTIBIOTICS. IT WAS REPORTED THE PATIENT DID NOT GET THE CAST WET AND HAD CONTACT DERMATITIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 3M SCOTCHCAST WET AND DRY CAST PADDING | (ITG) PROSTEHTIC AND ORTHOTIC ACCESS | ITG | 3M HEALTH CARE | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 16 YR | Other | NONE SPECIFIED |