MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-22 for 20 SILICONE PIP IMPLANT (STERILE PACKED) PIP20 manufactured by Stryker Gmbh.
[124655823]
Device will not be returned. If additional information becomes available it will be provided on a supplemental report.
Patient Sequence No: 1, Text Type: N, H10
[124655824]
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 patient: pain, swelling, local fluid drainage.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0008031020-2018-00885 |
| MDR Report Key | 7993226 |
| 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 | 0 |
| Brand Name | 20 SILICONE PIP IMPLANT (STERILE PACKED) |
| Generic Name | PROSTHESIS, FINGER, CONSTRAINED, POLYMER23 |
| Product Code | KYJ |
| Date Received | 2018-10-22 |
| Catalog Number | PIP20 |
| Lot Number | 03091V |
| 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 |