MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-19 for DISPOSABLE SCALPELS 22 4-422 manufactured by Integra York, Pa Inc..
[128254605]
The device was not 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
[128254606]
It was reported that on (b)(6) 2018, during a routine tissue processing procedure, a 4-422 disposable scalpels 22, broke in half. Additional information was received on (b)(6) 2018, stating that while the tech/processor was processing lung tissue and making sections, the scalpel snapped and broke, causing body fluid to spray into the processor? S face. Follow up infectious disease testing was required. Request for additional information has been sent.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2523190-2018-00142 |
| MDR Report Key | 8086251 |
| Date Received | 2018-11-19 |
| Date of Report | 2018-11-01 |
| Date of Event | 2018-10-30 |
| Date Mfgr Received | 2018-12-10 |
| Date Added to Maude | 2018-11-19 |
| 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 | 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 | DISPOSABLE SCALPELS 22 |
| Generic Name | M5 - GENERAL SURGERY |
| Product Code | GDX |
| Date Received | 2018-11-19 |
| Catalog Number | 4-422 |
| Lot Number | S18A12 |
| 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 | 2018-11-19 |