MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-10-22 for 30 SILICONE PIP IMPLANT (STERILE PACKED) PIP30 manufactured by Stryker Gmbh.
[124605479]
Device will not be returned. If additional information becomes available it will be provided on a supplemental report. Remains implanted.
Patient Sequence No: 1, Text Type: N, H10
[124605480]
Setting up autofix screw 2. 0. One month after appearance of an inflammatory phenomenon with redness and digital swelling in two patients. Inflammatory reaction and local discomfort for patients. This pi represents the second patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0008031020-2018-00884 |
| MDR Report Key | 7992294 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-10-22 |
| Date of Report | 2018-11-16 |
| Date of Event | 2018-08-23 |
| Date Mfgr Received | 2018-10-25 |
| Date Added to Maude | 2018-10-22 |
| 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 | MR. ANNA JUSINSKI |
| Manufacturer Street | 325 CORPORATE DRIVE |
| Manufacturer City | MAHWAH NJ 07430 |
| Manufacturer Country | US |
| Manufacturer Postal | 07430 |
| Manufacturer Phone | 2018315000 |
| Manufacturer G1 | STRYKER GMBH |
| Manufacturer Street | BOHNACKERWEG 1 POSTFACH |
| Manufacturer City | SELZACH 2545 |
| Manufacturer Country | CH |
| Manufacturer Postal Code | 2545 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 30 SILICONE PIP IMPLANT (STERILE PACKED) |
| Generic Name | PROSTHESIS, FINGER, CONSTRAINED, POLYMER23 |
| Product Code | KYJ |
| Date Received | 2018-10-22 |
| Catalog Number | PIP30 |
| Lot Number | 04912L |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER GMBH |
| Manufacturer Address | BOHNACKERWEG 1 POSTFACH SELZACH 2545 CH 2545 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-10-22 |