MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2014-06-04 for SHOULDER TRACTION KIT PKG 5 N/A 905026 manufactured by Biomet Orthopedics.
[4407703]
It was reported by a user facility that the shoulder traction device was attempted for use after shoulder procedures and the netting ripped, causing the patients? Arms to fall through. There were no reported injuries to the patients as a result.
Patient Sequence No: 1, Text Type: D, B5
[11961762]
The product identification necessary to review manufacturing history was not provided. Current information is insufficient to permit a conclusion as to the cause of the event. The following sections could not be completed with the limited information provided. Expiration date & lot number- unknown, manufacture date? Unknown.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0001825034-2014-05194 |
| MDR Report Key | 3849670 |
| Report Source | 06 |
| Date Received | 2014-06-04 |
| Date of Report | 2014-05-09 |
| Date Mfgr Received | 2014-05-09 |
| Date Added to Maude | 2014-07-03 |
| 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 | MS. AMANDA ZAJICEK |
| Manufacturer Street | 56 E. BELL DRIVE |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal | 46582 |
| Manufacturer Phone | 5743726782 |
| Manufacturer G1 | BIOMET ORTHOPEDICS |
| Manufacturer Street | 56 E. BELL DRIVE |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 46582 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SHOULDER TRACTION KIT PKG 5 |
| Generic Name | SPLINT, TRACTION |
| Product Code | HSP |
| Date Received | 2014-06-04 |
| Model Number | N/A |
| Catalog Number | 905026 |
| Lot Number | UNKNOWN |
| ID Number | N/A |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOMET ORTHOPEDICS |
| Manufacturer Address | 56 E. BELL DRIVE WARSAW IN 46582 US 46582 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-06-04 |