MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2013-10-10 for SCHUK FLPL-SS WIRE PISTON 140126 manufactured by Gyrus Ent L.l.c., Sub. Of Gyrus Acmi, Inc..
[22194751]
It was reported that when the physician opened the package of the device to use for the procedure, she found the wire of piston was bent. She opened another package of same model but she found the wire was also bent. Based upon the physician's decision, the bent wire was placed in the patient after she transformed the wire. Around the end of august, the physician detected the hearing of the patient wasn't improved during follow-up check. On (b)(6), omsc got this info from the facility. On (b)(6), omsc got add'l info from the facility. The hearing of the patient is improved gradually. "
Patient Sequence No: 1, Text Type: D, B5
[22212999]
At the time of this report, the device has not yet been returned for eval. As a result, a determination cannot be made at this time. If further info becomes available, gyrus (b)(4) will continue the investigation and update the agency accordingly.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1037007-2013-00015 |
| MDR Report Key | 3413022 |
| Report Source | 05 |
| Date Received | 2013-10-10 |
| Date of Report | 2013-09-13 |
| Date of Event | 2013-08-12 |
| Date Mfgr Received | 2013-09-13 |
| Device Manufacturer Date | 2012-06-01 |
| Date Added to Maude | 2013-10-17 |
| 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 | TERRENCE SULLIVAN |
| Manufacturer Street | 136 TURNPIKE ROAD |
| Manufacturer City | SOUTHBOROUGH MA 01772 |
| Manufacturer Country | US |
| Manufacturer Postal | 01772 |
| Manufacturer Phone | 5088042739 |
| Manufacturer G1 | GYRUS ENT L.L.C., SUB. OF GYRUS ACMI, INC. |
| Manufacturer Street | 2925 APPLING RD. |
| Manufacturer City | BARTLETT TN 38133 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 38133 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SCHUK FLPL-SS WIRE PISTON |
| Generic Name | SCHUK FLPL-SS WIRE PISTON |
| Product Code | ETB |
| Date Received | 2013-10-10 |
| Model Number | 140126 |
| Catalog Number | 140126 |
| Lot Number | MH463318 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GYRUS ENT L.L.C., SUB. OF GYRUS ACMI, INC. |
| Manufacturer Address | 2925 APPLING RD. BARTLETT TN 38133 US 38133 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2013-10-10 |