MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2018-12-19 for AFFLOVEST 8200 manufactured by International Biophysics Corporation.
[130793011]
The patient's underlying pathology and medication may have contributed to the fractured ribs. The patient did not allege the device malfunctioned. The device was returned to ibc for investigation, and the device met all acceptance criteria.
Patient Sequence No: 1, Text Type: N, H10
[130793012]
Respiratory therapist was informed that the user suffered several broken ribs.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1645362-2018-00005 |
| MDR Report Key | 8178717 |
| Report Source | DISTRIBUTOR |
| Date Received | 2018-12-19 |
| Date of Report | 2018-11-26 |
| Date of Event | 2018-10-20 |
| Date Mfgr Received | 2018-10-29 |
| Device Manufacturer Date | 2018-09-06 |
| Date Added to Maude | 2018-12-19 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. GEOFFREY MARCEK |
| Manufacturer Street | 2101 E. ST. ELMO ROAD SUITE 275 |
| Manufacturer City | AUSTIN TX 78744 |
| Manufacturer Country | US |
| Manufacturer Postal | 78744 |
| Manufacturer Phone | 5128140046 |
| Manufacturer G1 | INTERNATIONAL BIOPHYSICS CORPORATION |
| Manufacturer Street | 2101 E. ST. ELMO ROAD SUITE 275 |
| Manufacturer City | AUSTIN TX 78744 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 78744 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AFFLOVEST |
| Generic Name | IBC HFCWO VIBRATORY VEST |
| Product Code | BYI |
| Date Received | 2018-12-19 |
| Returned To Mfg | 2018-11-15 |
| Model Number | 8200 |
| Catalog Number | 8200 |
| Lot Number | 090618-6642 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTERNATIONAL BIOPHYSICS CORPORATION |
| Manufacturer Address | 2101 E. ST. ELMO ROAD SUITE 275 AUSTIN TX 78744 US 78744 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2018-12-19 |