MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2018-09-07 for GARRETT DILATOR 5-1/2 X 1.0MM 310396 manufactured by Integra York, Pa Inc..
[119813942]
The device was not yet returned to the manufacturer for analysis. The plant investigation is in progress and a supplemental medwatch report will be submitted upon completion of the investigation.
Patient Sequence No: 1, Text Type: N, H10
[119813943]
It was reported that the garrett dilator 5-1/2 x 1. 0mm tip breaks off. The tip broke off in a patient. It is unknown it there was any patient injury or a delay in surgery. Additional request for information has been sent.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2523190-2018-00116 |
| MDR Report Key | 7857460 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-09-07 |
| Date of Report | 2018-08-15 |
| Date Mfgr Received | 2018-09-04 |
| Date Added to Maude | 2018-09-07 |
| 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 | 3 |
| Brand Name | GARRETT DILATOR 5-1/2 X 1.0MM |
| Generic Name | CARDIOVASCULAR GENERAL |
| Product Code | DWP |
| Date Received | 2018-09-07 |
| Catalog Number | 310396 |
| Lot Number | 235458 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2018-09-07 |