MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-06-02 for DOC CRANIAL BANDING HELMET DOC BRAND CRANIAL BANDING HELMET manufactured by Cranial Technologies.
[18093571]
Cranial banding helmet (cranial technologies doc brand) caused direct injury to (b)(6) infant. The moleskin adhesive applied to the interior of the helmet by cranial technologies clinician after helmet adjustment visit became undone and "rolled" onto itself during overnight sleep period causing a large forehead pressure wound with resultant hematoma, edema, and skin scarring. Additional pressure wounds on the lateral and posterior scalp also noted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5043010 |
| MDR Report Key | 4834840 |
| Date Received | 2015-06-02 |
| Date of Report | 2015-06-02 |
| Date of Event | 2015-05-22 |
| Date Added to Maude | 2015-06-11 |
| 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 | 0 |
| Reporter Occupation | PATIENT FAMILY MEMBER OR FRIEND |
| Health Professional | 0 |
| 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 | DOC CRANIAL BANDING HELMET |
| Generic Name | DOC CRANIAL BANDING HELMET |
| Product Code | MVA |
| Date Received | 2015-06-02 |
| Model Number | DOC BRAND CRANIAL BANDING HELMET |
| ID Number | DOC BRAND |
| Operator | LAY USER/PATIENT |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CRANIAL TECHNOLOGIES |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2015-06-02 |