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 2018-07-11 for DISP DERMAL CURETTES 5 MM manufactured by Integra York Pa, Inc..
[113644048]
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
[113644049]
Clinical projects manager reported that on (b)(6) 2018, a 33-55 disp dermal curettes 5mm was dull and unable to remove calluses with them and "it would take out chucks". It was reported to have caused bleeding which required treatment with silver nitrate. Additional information was requested.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2523190-2018-00083 |
| MDR Report Key | 7677235 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-07-11 |
| Date of Report | 2018-07-11 |
| Date of Event | 2018-06-12 |
| Date Mfgr Received | 2018-07-13 |
| Date Added to Maude | 2018-07-11 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | DISP DERMAL CURETTES 5 MM |
| Generic Name | M3-DERMAL |
| Product Code | FZS |
| Date Received | 2018-07-11 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA YORK PA, INC. |
| Manufacturer Address | 589 DAVIES DRIVE YORK PA 17402 US 17402 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2018-07-11 |