MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2000-08-15 for ALL-FLEX ARCING SPRING DIAPHRAGM UNK manufactured by R.w. Johnson Pharm. Res. Inst. Usa / Div Of Ortho Pharmaceutical Corp..
[245134]
Additional information 05-jul-01: physician returned the medwatch form which had been sent to him for this review. A notation of "no changes" was made on the medwatch form.
Patient Sequence No: 1, Text Type: D, B5
[15038096]
Spontaneous report from a pt who used an all-flex arcing spring diaphragm (size 70) for the second time and could not remove the diaphragm 6 hours after use because it was stuck. Another attempt to remove at 12 hours after use was also unsuccessful. The diaphragm was successfully removed 20 hours after use. Three hours after removal the pt developed a fever (9:30 pm) and at 12:00 midnight pt developed uncontrollable vomiting that continued to 3:45am. The pt presented to the emergency room with a temperature of 103. 1 degrees, diarrhea, dizziness, red face and neck resembling sunburn. Toxic shock syndrome was suspected and the pt was transferred to the intensive care unit of a larger hospital. Pt was treated with intravenous and oral antibiotics and recovered.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2211100-2000-00105 |
| MDR Report Key | 290156 |
| Report Source | 04 |
| Date Received | 2000-08-15 |
| Date of Report | 2000-07-25 |
| Date of Event | 2000-06-30 |
| Date Mfgr Received | 2000-07-20 |
| Date Added to Maude | 2000-08-17 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Street | 920 U.S. ROUTE 202 PO BOX 300 |
| Manufacturer City | RARITAN NJ 08869 |
| Manufacturer Country | US |
| Manufacturer Postal | 08869 |
| Manufacturer Phone | 9087044504 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ALL-FLEX ARCING SPRING DIAPHRAGM |
| Generic Name | DIAPHRAGM |
| Product Code | HDW |
| Date Received | 2000-08-15 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | 17A854 |
| ID Number | UNK |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 280814 |
| Manufacturer | R.W. JOHNSON PHARM. RES. INST. USA / DIV OF ORTHO PHARMACEUTICAL CORP. |
| Manufacturer Address | 920 U.S. ROUTE 202 PO BOX 300 RARITAN NJ 08869 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Life Threatening | 2000-08-15 |