MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,06 report with the FDA on 2014-04-16 for HAND DRILL - STERILE INS030 manufactured by Integra Pain Management.
[4569757]
This is the second of two reports regarding ins030 (hand drill - sterile) (same product id, different lot numbers). It was reported that there was discoloration on the inside package; there was a strain on the packaging itself. Both product were opened. The products were use when they noticed the stain. Additional information has been requested.
Patient Sequence No: 1, Text Type: D, B5
[11973754]
To date, the device involved in the reports incident has not been received by evaluation. An investigation has been initiated based upon the reported information.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1722447-2014-00009 |
| MDR Report Key | 3871618 |
| Report Source | 04,06 |
| Date Received | 2014-04-16 |
| Date of Report | 2014-03-27 |
| Date Mfgr Received | 2014-03-27 |
| Date Added to Maude | 2014-06-27 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | ROWENA BUNUDAN |
| Manufacturer Street | 315 ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099362393 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HAND DRILL - STERILE |
| Generic Name | NA |
| Product Code | HBG |
| Date Received | 2014-04-16 |
| Catalog Number | INS030 |
| Lot Number | W1305159 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA PAIN MANAGEMENT |
| Manufacturer Address | SALT LAKE CITY UT 84104 US 84104 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-04-16 |