MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-07-25 for DISP DERMAL CURETTES 5MM 33-55 manufactured by Integra York, Pa Inc..
[115376228]
The device was not returned to the manufacturer for physical evaluation, therefore the failure mode could not be confirmed. The root cause cannot be determined due to the lack of information received to perform a complete investigation. Product has not been returned for evaluation.
Patient Sequence No: 1, Text Type: N, H10
[115376229]
The regulatory affairs associate reported on behalf of the customer that on (b)(6) 2018, a 33-55 disp dermal curettes 5mm was dull and unable to perform a conservative sharp debridement. No injury or surgery delay was reported. Additional information was requested.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2523190-2018-00097 |
| MDR Report Key | 7719619 |
| Date Received | 2018-07-25 |
| Date of Report | 2018-07-06 |
| Date of Event | 2018-06-19 |
| Date Mfgr Received | 2018-07-06 |
| Date Added to Maude | 2018-07-25 |
| 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 | DISP DERMAL CURETTES 5MM |
| Generic Name | M3 - DERMAL |
| Product Code | FZS |
| Date Received | 2018-07-25 |
| Catalog Number | 33-55 |
| Lot Number | 180204 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| 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 | 2018-07-25 |