MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-03-26 for SUTURE GRASPER 3.5 MM 214575 manufactured by Depuy Mitek Llc Us.
[139883313]
Product complaint #: (b)(4). If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. Udi: (b)(4). The lot number is not currently available.
Patient Sequence No: 1, Text Type: N, H10
[139883314]
It was reported by the affiliate that the device broke. It was noted there was no impact to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1221934-2019-56694 |
| MDR Report Key | 8452750 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-03-26 |
| Date of Report | 2019-02-28 |
| Date of Event | 2019-01-01 |
| Date Mfgr Received | 2019-04-23 |
| Date Added to Maude | 2019-03-26 |
| 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 | KARA DITTY-BOVARD |
| Manufacturer Street | 325 PARAMOUNT DRIVE |
| Manufacturer City | RAYNHAM MA 02767 |
| Manufacturer Country | US |
| Manufacturer Postal | 02767 |
| Manufacturer Phone | 5089776860 |
| Manufacturer G1 | DEPUY MITEK LLC US |
| Manufacturer Street | 325 PARAMOUNT DRIVE |
| Manufacturer City | RAYNHAM MA 02767 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 02767 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SUTURE GRASPER 3.5 MM |
| Generic Name | SUTURE/NEEDLE PASSER, REUSABLE |
| Product Code | HCF |
| Date Received | 2019-03-26 |
| Catalog Number | 214575 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEPUY MITEK LLC US |
| Manufacturer Address | 325 PARAMOUNT DRIVE RAYNHAM MA 02767 US 02767 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-03-26 |