MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-04-12 for HALSTEAD FCPS 5 CVD MATTE 107102 manufactured by Integra York, Pa Inc..
[105775724]
The device was not returned to the manufacturer for physical evaluation, therefore the failure mode cannot be confirmed. However, an investigation of the device manufacturing records was conducted by the manufacturer. There were no deviations or non-conformances during the manufacturing process. In addition, the device history record review confirmed the labeling, material, and process controls were within specification.
Patient Sequence No: 1, Text Type: N, H10
[105775725]
A regulatory affairs manager reported to integra that a medwatch report was received with (b)(4), the following information was: a risk manager reported that a 107102 halstead fcps 5 cvd matte was used on (b)(6) 2018 during an unspecified procedure. During surgery, it was discovered that a mosquito clamp was missing a piece from one side of the clamp tip. The clamp was used in the wound and the tip could not be accounted for. No patient injury or surgery delay was reported. Additional information has been requested.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2523190-2018-00049 |
| MDR Report Key | 7424911 |
| Date Received | 2018-04-12 |
| Date of Report | 2018-03-16 |
| Date of Event | 2018-01-18 |
| Date Mfgr Received | 2018-03-16 |
| Date Added to Maude | 2018-04-12 |
| 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 | USER KIMBERLY SHELLY |
| Manufacturer Street | 311 ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099362393 |
| Manufacturer G1 | INTEGRA YORK, PA INC. |
| Manufacturer Street | 589 DAVIES DRIVE |
| Manufacturer City | YORK PA 17402 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 17402 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | HALSTEAD FCPS 5 CVD MATTE |
| Generic Name | N/A |
| Product Code | HRQ |
| Date Received | 2018-04-12 |
| Catalog Number | 107102 |
| Lot Number | 101707-1405 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA YORK, PA INC. |
| Manufacturer Address | 589 DAVIES DRIVE 589 DAVIES DRIVE YORK PA 17402 US 17402 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-04-12 |